Learning Center
Embolization Coiling: The Importance of Material selection
Embolization coiling is a minimally invasive catheter-based procedure that employs a coil that can cause an occlusion. What’s important is that the design is made easy to handle and produces the desired effect at the intended location.
China MAH Policy Changes and The massive Opportunity for Medical Device OEMs
The new MAH or Marketing Authorization Holder Policy has opened up a whole new level of opportunities for medical device companies. OEMs must capitalize on the major changes taking place in the Chinese market in allowing high-quality medical devices to be manufactured and marketed without as many restrictions as they experienced prior to the MAH Policy.
Optimal Medical Device Prototyping for Getting to Market Sooner
If these core elements are not carefully assessed, planned and tested through prototyping, the problems arising at the FDA approval stage, production stage and usage with the end-users will negate profitability
Biocompatibility Challenges in Structural Heart Device
The biocompatibility of materials used in Structural Heart Devices is of the utmost importance. We explore the challenges presented by each material’s specific functional profile and how it will react when used in a Structural Heart (SH) Device
The Impact of Quasar’s Crisis Leadership Through Covid-19
As rumors of Covid-19 spread in January 2020, and fear gripped most of China, the management had to face facts and realize that a serious crisis was in the offing. Instead of being paralyzed by fear and uncertainty, Quasar’s leadership headed by Ayal Amitai, CEO, began looking ahead, considering courses of action to get the plant working again.
A Second Medical Device Manufacturing Source As a Risk Mitigation Strategy
Many supply-chain vulnerabilities stem from long lead times and high levels of cyclicity that prevent the maintenance of the right inventory balance. OEM companies must identify and solve supply-chain vulnerabilities and risk exposures by creating effective mitigation and business-continuity plans.
Automation Trends in Medical Device Manufacturing
Today’s advancements in automation systems are evolving at a fast pace. All while becoming more cost-effective to install and maintain.
6 Advantages of Medical Device Manufacturing in China Post Covid-19
China’s overall economic recovery in part has been attributed to the strong rebound in the manufacturing sector. The medical devices manufacturing sector specifically recorded an astounding 46.4% growth.
Benefits of Transferring Production to An Experienced Contract Manufacturer
The benefits of transferring production to an experienced contract manufacturer with a track record for performance is the plethora of ideas and innovation that adds more value to the design of the end product.
Interventional Cardiology Equipment: Top Advancements of 2020
It takes veteran manufacturers who are specialized in the field of interventional cardiology equipment, to be able to smoothly navigate through this ever-evolving market.
How Automation Benefits Your Bottom Line in Medical Device Production
From one-off and per-item costs to quality, repeatability, and customer satisfaction. Strategically automating a process provides the best way to ensure the medical device’s manufacturing success.
Announcement: Quasar Expands to North America with Commercial Headquarters in Minnetonka, Minnesota
“Expanding our global footprint to North America strengthens our commitment to support our current USA customers with direct staff, while positioning Quasar to service new customers with our unique capabilities and technologies.” – Ayal Amitai, CEO
Strategic Considerations in Selecting a Low-Cost Country for Medical Device Manufacturing
Finding the right low-cost country for medical device manufacturing can play a key role in gaining a competitive advantage for your product. The leading regions are South America, Mexico, and Asia. As per our analysis, Asia is where you will find the most advantages when considering the supply chain as the key success factor.
Outsourcing Medical Device Manufacturing – OEM Top Concerns
Outsourcing the production of your medical device manufacturing can be a big step for your organization. As an Original Equipment Manufacturer (OEM), putting your product in the hands of a Contract Manufacturer (CM) will free up significant time for your design and production teams, streamline the manufacturing process and even give you access to new world markets.
Exceptional Quality with Cost-Effective Solutions Secrets of a Medical Device Contract Manufacturer
For an OEM, the prospect of outsourcing manufacturing should be an attractive way to cut costs and simplify a new product workflow. The purpose of this article is to take a closer look at how a Contract Manufacturer (CM) can help an OEM save money and work more efficiently.
Key Elements of Maintaining a Stable Supply Chain During Covid-19
A supplier’s slow return to operations threatens your ability to deliver – Here is how Quasar successfully maintained a stable supply chain during Covid-19
Advantages Of A Full Service Medical Device Contract Manufacturer
If you’re considering outsourcing your manufacturing process, it’s recommended to look for a partner who can offer end-to-end service. Or a full-service medical device contract manufacturer. Finding the right partner who can help refine your design before diving into production will save big on time and money.
Why 2021 is the Year to Capitalize on China’s Medical Device Market
China’s medical device market is enormous. The medical device industry makes up more than $96 billion in healthcare spending, and that number has been growing at a more than 20% pace for several years.
Medical Device Document Control: What To Expect From A Contract Manufacturer
We rely on these best practices for the most efficient change control board process. This ensures that the medical devices we produce are constantly improving and meeting customers’ demands while also continuously meeting existing safety and quality standards.
Return of the Workforce During the COVID-19 Lockdown in China
When the Chinese government allowed manufacturers to re-open in the wake of the COVID-19 lockdown, Quasar and other companies couldn’t simply flip a switch to restart production. One of the biggest challenges manufacturers faced was in finding ways to bring the workforce back to the plant. In Quasar’s case, the majority of our 1,400-person workforce was spread across many different regions of the country.
How to Create an Efficient Change Control Board Process
The FDA and other health authorities require for every medical device to meet production standards. Process validation is crucial for meeting these standards and bringing your new medical device to market.
COVID-19 Case Study: A Demonstration of Resilience and Operational Excellence
How Quasar was able to ensure the safe return of over 1,300 employees with zero cases of infection found and resumed operations in just 3 weeks.
Considerations for Setting a Process Validation for Your Medical Device
The FDA and other health authorities require for every medical device to meet production standards. Process validation is crucial for meeting these standards and bringing your new medical device to market.
5 Considerations For Selecting Medical Device Materials
Material selection for your medical device is so important. If done wrong it can hurt your business, but if done right, it can aid in your product’s commercial success. Depending on your medical device, the task of selecting the right materials can be as simple as it can be daunting. Moreover, your material selection directly ties in to major design choices that you will take, based on those material’s attributes.
How to Determine the Critical Testing Methods for a Medical Device
Testing is a crucial part of the manufacturing process which ensures your medical product delivers top results. In today’s world health crisis and economic disarray, quality and precision of your medical products need to be a top priority. Because in medical device manufacturing, there is simply no room for shortcuts.
The Future of Instruments for Minimally Invasive Surgery
What are the areas of innovation that will continue to further advance minimally invasive surgery as the operating method of choice? In this article, we take a look at some of the future developments we look forward to seeing.
Advancements in Today’s Electronic Medical Device Industry
Advancements in mobile technologies, flexible circuits, microelectronics, and embedded systems have played a major role in the emergence of novel medical devices and healthcare solutions. So what are the most significant advancements in today’s electronic medical device industry?
Balloon Catheter Design and Manufacturing
Balloon catheters production requires extensive know how. In this article, we discuss the design considerations, as well as take a look at manufacturing overview of balloon catheters.
How to Conduct an OEM Audit for a Medical Contract Manufacturer
Conducting a medical device manufacturer audit, includes a multitude of items to examine. Especially when considering the gamut of OEM activities: from simpler manufacturing operations, to vertical production facilities. In this article we cover the most important items to consider, as well as some additional factors that demonstrate above average OEM operations.
Case Study: Medical Device Packaging Considerations
Packaging is an often neglected aspect of medical device design. Depending on the case, packaging can have a significant impact on a medical device’s user experience, practicality, cost, and overall success.
Cardiovascular Medical Devices: The Latest Innovations
In this article, we take a look at some of these latest innovations in cardiovascular medical devices.
EU MDR 2020: What to Expect
The EU MDR allowed a 3-year transition period for medical device manufacturers to comply. This runway ends in May 2020, where after the EU MDR comes into full effect. After this point, every part of the medical device supply chain from manufacturers to importers and distributors in the EU, will be required to comply.
Medical Product Outsourcing VS. In-House Manufacturing
Medical Product Outsourcing VS. In-House Manufacturing
The OEM Medical Device and Contract Manufacturer Relationship
Top medical device contract manufacturers have the ability to provide comprehensive services for their OEM partners. In this article we take look at how those attributes can be maximized when a strong and healthy relationship exists.
Trends in Applications and Technologies Used by Catheter Manufacturers Today
In this article we take a look at the applications and technologies that medical device manufacturers use today, to meet the demanding conditions of catheter manufacturing.
Quasar Excited to Announce Expansion of Services to Partners in China
A groundbreaking Chinese government policy change in August 2019 by the National Medical Products Administration (NMPA) will now grant any CFDA registered Contract Manufacturer the opportunity to become a Product Registered Manufacturing Contractor in China. Quasar is positioned to expand its abilities to manufacture, obtain necessary cross regional licensing, and participate as a government approved fully licensed registrant.
Medical Device Contract Manufacturing: How to Find the Right Fit for My Product?
In this article we look into why it’s important to find the right medical device contract manufacturer, as well as important factors to consider in your selection.
How to Conduct FMEA for Disposable Medical Device
FMEA, a method that helps medical device manufacturers identify, break down, control and review the risks associated with product development and manufacturing.
When is a Quality Management System (QMS) needed for Medical Devices?
Medical device companies can experience difficulty determining when to start setting up a Quality Management System (QMS). The time range required to fully establish a QMS is between 3 to 9 months. In this article, we take an overview look of what a QMS is and when you need to have one in place.
Common Mistakes when Transferring Medical Device Manufacturing to High Volume
In the following article we cover some of the common mistakes that are made when transferring medical device manufacturing to high volume. The ability to identify these areas at an early stage together with proper management, can be critical to a medical device’s lifecycle. These common pitfalls that result in costly corrective actions can be avoided altogether.
Case Study: Plastic Molding DFM
Introduction It’s not uncommon for companies to seek a device manufacturer after having completed the prototype development phase. That’s because they mistakenly assume that the product development team has manufacturability in mind. On the contrary, however, experience shows that during development, engineers will focus on design outputs to meet the design inputs. And not enough focus goes into product manufacturability as is necessary. It is absolutely critical to involve the device manufacturer from early on in the design phase. Otherwise, companies run the risk of developing products that will have issues with manufacturability that pose serious challenges in later stages. This study [...]
Q&A: All you Need to Know About the New EU Medical Device Regulation (MDR)
This article is a brief summary in the form of a Q&A, about the key changes and most important points of the new EU medical device regulation.
FDA Medical Device Classification: Process Explained
In this article we outline the FDA medical device classification process.
The Quasar team looks forward to seeing you at BIOMEDevice
Let’s find a time to meet and discuss how we can help with your product. We are exited to showcase our special abilities in contract manufacturing for medical devices with companies in all stages of the product cycle in the great city of Boston. Booth #229
5 Things You Need to Know about the Israeli Medical Device Industry Today
Israel is considered to be amongst the world leaders in the field of medical devices. The total number of granted patents in the area of medical devices, positions Israel at the first place in the world in patents per capita, and in the fourth place in terms of absolute number of patents.
The Golden Path Towards Mass Production
Quasar partners with MedNet GmbH, a Germany-based, international service provider for the medical contract manufacturing industry.
Assessing Risk: 5 Tips for Medical Device Risk Management
What is Risk Management Risk assessment in medical device manufacturing is an ongoing responsibility and must be managed and perceived as a top priority in the organization. Risk management is a framework used to identify, evaluate, and mitigate risk or potential failures throughout a medical device’s development life cycle. It is an integral part of the process of medical device development and manufacturing, utilized to ensure a medical devices’ effectiveness, reliability, and safety for patients and operators alike. Risk Management Standards for the Medical Device Industry Risk management standards for the medical device industry, are defined by the ISO 14971 quality standard, as [...]
Medical Device Product Development: Make the Process Work for Your Product
Medical Device Product Development: How to Make The Process Work For Your Product The medical device design and development process consists of four main phases from start to finish of a medical device’s product lifecycle: conception, design & development, technology transfer, and mass manufacturing. The following is a simple step-by -step approach on how to make the medical device design and development process work for your product, pertaining to every medical device design and development process phase respectively. These factors are key to quick and successful time to market. Conception From as early as the product conception phase, care should be taken to [...]
Why ISO 13485 Might Not Be Enough for Your Medical Device Manufacturing Process
ISO 13485 manufacturing is an established quality standard, pertaining to medical device manufacturers. However, as with any quality standard, it is more a set of general guidelines which every manufacturer applies to their own situation according to their status, infrastructure, and working conditions, rather than a recipe for success. There are multiple ways in which it can be applied to each manufacturer’s case, therefore making each medical device manufacturer responsible for guaranteeing their operational effectiveness and success, independent of their ISO 13485 manufacturing certification. An Overview Of ISO 13485 Manufacturing Quality Standard First published in 1996, ISO 13485 in manufacturing is [...]
A Simplified Introduction to Medical Device Design Control
Often, when working on developing a medical device and its design control, designers and engineers find themselves stuck or having to repeat the same processes, again and again, to fix and perfect their design. Considering these seven common steps for design and control of medical devices can help a team avoid some of the most common pitfalls. Since 1990 and 1993, the US (21 CFR 820.30) and EU (MDD 93/42/EEC) respectively included Medical Devices in their GMP (Good Manufacturing Practices) set of rules and regulations, with the International Standards Organization (ISO) following suit in 1996 by publishing their voluntary ISO [...]
The Four Phases of Medical Device Product Development Lifecycle
The Four Phases of Medical Device Product Development Lifecycle 1. Conception This phase contains several steps from idea conception, the use context of the medical device, initial concept development, up to proof of concept. These ideation processes generate abstract concepts in need of further development, refinement, and adaptation, to result in a workable base for developing a medical device that is effective to use, feasible to produce, and can achieve regulatory compliance. 2. Design & Development New Process Development (NPD) Medical device product design should be carried out with manufacturing in mind. From the early stages of device components design, factors such as practical [...]
Quasar’s new top-technology production facility
We are happy to announce the opening of our new manufacturing facility in Dongguan, China. The facility is now in the validation phase and will fully operational for mass production during Q1-2018. The new facility is our newest asset in our effort to deliver higher quality and newer technologies for innovative medical device mass production and process-design services. Share With Colleagues [sharethis-inline-buttons]
QUASAR announces new alliance with MedNet GmbH
Quasar partners with MedNet GmbH, a Germany-based, international service provider for the medical contract manufacturing industry.
Quasar passes ISO 13485 Surveillance with no nonconformities
In Dec 2016, BSI Auditors pored over DHRs, validations and quality objectives; then toured the lines and reviewed procedures during Quasar’s annual audit. We are happy to announce that Quasar was found ISO 13485 compliant, surpassing requirements in every category.
Quasar passes FDA inspection with no 483 findings
An FDA audit was conducted from October 31 to November 3 at the Quasar manufacturing facility in Shenzhen. This is the second consecutive audit Quasar has passed, by the FDA, and the result with NO findings in non-conformance (no 483) endorses Quasar’s renewed commitment to being a qualified medical device manufacturer. Consistent with Quasar’s legacy of maintaining high quality standards, quality is focused on throughout the entire production process, starting from development, and maintained through all phases to manufacturing.
quasar launches new BRANDING
Quasar is pleased to launch its official new BRAND, revealing the company’s strategic change in direction to reflect its focus on the medical device market. Our NEW BRANDING
The Secret of Entering The Automated Assembly Trend
Obamacare and Europe’s economic situation are exerting significant cost pressures on Medical Devices. Leading manufacturers are meeting these pressures with semi and full automation, even at their low-cost locations. The benefits are
QIL expands with larger offices and laboratory
In the first quarter of 2016, QIL, Quasar subsidiary in Israel, expend its offices and laboratory. This expansion is in line with Quasar’s growth and advancement within the medical market.
Quasar targets the medical market for strategic focus
The market for medical devices is growing rapidly, requiring the highly skilled manual assembly of numerous components. This specialized assembly and production necessitates a trusted manufacturing partner.
NPI | New Product Implementation
The product then moves to the new product implementation (NPI) phase.
NPD | New Product Development
Manufacturing excellence begins in the planning stages, even before production commences. The company initiates the first phase, new product development (NPD) process in complete coordination with the customer.
Achieving excellence in Mass production |Product Development and Implementation
Outsourcing mass production overseas carries the challenge of ensuring the consistency and quality of each product – especially when multiplied by large volumes.
New technology in Quasar equipment – New Laser Machine
QUASAR is announcing the addition of a new laser welding equipment to it’s manufacturing facility in Shenzhen, China.
Embolization Coiling: The Importance of Material selection
Embolization coiling is a minimally invasive catheter-based procedure that employs a coil that can cause an occlusion. What’s important is that the design is made easy to handle and produces the desired effect at the intended location.
China MAH Policy Changes and The massive Opportunity for Medical Device OEMs
The new MAH or Marketing Authorization Holder Policy has opened up a whole new level of opportunities for medical device companies. OEMs must capitalize on the major changes taking place in the Chinese market in allowing high-quality medical devices to be manufactured and marketed without as many restrictions as they experienced prior to the MAH Policy.
Optimal Medical Device Prototyping for Getting to Market Sooner
If these core elements are not carefully assessed, planned and tested through prototyping, the problems arising at the FDA approval stage, production stage and usage with the end-users will negate profitability
Biocompatibility Challenges in Structural Heart Device
The biocompatibility of materials used in Structural Heart Devices is of the utmost importance. We explore the challenges presented by each material’s specific functional profile and how it will react when used in a Structural Heart (SH) Device
The Impact of Quasar’s Crisis Leadership Through Covid-19
As rumors of Covid-19 spread in January 2020, and fear gripped most of China, the management had to face facts and realize that a serious crisis was in the offing. Instead of being paralyzed by fear and uncertainty, Quasar’s leadership headed by Ayal Amitai, CEO, began looking ahead, considering courses of action to get the plant working again.
A Second Medical Device Manufacturing Source As a Risk Mitigation Strategy
Many supply-chain vulnerabilities stem from long lead times and high levels of cyclicity that prevent the maintenance of the right inventory balance. OEM companies must identify and solve supply-chain vulnerabilities and risk exposures by creating effective mitigation and business-continuity plans.
Interventional Cardiology Equipment: Top Advancements of 2020
It takes veteran manufacturers who are specialized in the field of interventional cardiology equipment, to be able to smoothly navigate through this ever-evolving market.
How Automation Benefits Your Bottom Line in Medical Device Production
From one-off and per-item costs to quality, repeatability, and customer satisfaction. Strategically automating a process provides the best way to ensure the medical device’s manufacturing success.
Announcement: Quasar Expands to North America with Commercial Headquarters in Minnetonka, Minnesota
“Expanding our global footprint to North America strengthens our commitment to support our current USA customers with direct staff, while positioning Quasar to service new customers with our unique capabilities and technologies.” – Ayal Amitai, CEO
Strategic Considerations in Selecting a Low-Cost Country for Medical Device Manufacturing
Finding the right low-cost country for medical device manufacturing can play a key role in gaining a competitive advantage for your product. The leading regions are South America, Mexico, and Asia. As per our analysis, Asia is where you will find the most advantages when considering the supply chain as the key success factor.
Outsourcing Medical Device Manufacturing – OEM Top Concerns
Outsourcing the production of your medical device manufacturing can be a big step for your organization. As an Original Equipment Manufacturer (OEM), putting your product in the hands of a Contract Manufacturer (CM) will free up significant time for your design and production teams, streamline the manufacturing process and even give you access to new world markets.
Exceptional Quality with Cost-Effective Solutions Secrets of a Medical Device Contract Manufacturer
For an OEM, the prospect of outsourcing manufacturing should be an attractive way to cut costs and simplify a new product workflow. The purpose of this article is to take a closer look at how a Contract Manufacturer (CM) can help an OEM save money and work more efficiently.
Key Elements of Maintaining a Stable Supply Chain During Covid-19
A supplier’s slow return to operations threatens your ability to deliver – Here is how Quasar successfully maintained a stable supply chain during Covid-19
Advantages Of A Full Service Medical Device Contract Manufacturer
If you’re considering outsourcing your manufacturing process, it’s recommended to look for a partner who can offer end-to-end service. Or a full-service medical device contract manufacturer. Finding the right partner who can help refine your design before diving into production will save big on time and money.
Why 2021 is the Year to Capitalize on China’s Medical Device Market
China’s medical device market is enormous. The medical device industry makes up more than $96 billion in healthcare spending, and that number has been growing at a more than 20% pace for several years.
Medical Device Document Control: What To Expect From A Contract Manufacturer
We rely on these best practices for the most efficient change control board process. This ensures that the medical devices we produce are constantly improving and meeting customers’ demands while also continuously meeting existing safety and quality standards.
Return of the Workforce During the COVID-19 Lockdown in China
When the Chinese government allowed manufacturers to re-open in the wake of the COVID-19 lockdown, Quasar and other companies couldn’t simply flip a switch to restart production. One of the biggest challenges manufacturers faced was in finding ways to bring the workforce back to the plant. In Quasar’s case, the majority of our 1,400-person workforce was spread across many different regions of the country.
How to Create an Efficient Change Control Board Process
The FDA and other health authorities require for every medical device to meet production standards. Process validation is crucial for meeting these standards and bringing your new medical device to market.
COVID-19 Case Study: A Demonstration of Resilience and Operational Excellence
How Quasar was able to ensure the safe return of over 1,300 employees with zero cases of infection found and resumed operations in just 3 weeks.
Considerations for Setting a Process Validation for Your Medical Device
The FDA and other health authorities require for every medical device to meet production standards. Process validation is crucial for meeting these standards and bringing your new medical device to market.
5 Considerations For Selecting Medical Device Materials
Material selection for your medical device is so important. If done wrong it can hurt your business, but if done right, it can aid in your product’s commercial success. Depending on your medical device, the task of selecting the right materials can be as simple as it can be daunting. Moreover, your material selection directly ties in to major design choices that you will take, based on those material’s attributes.
How to Determine the Critical Testing Methods for a Medical Device
Testing is a crucial part of the manufacturing process which ensures your medical product delivers top results. In today’s world health crisis and economic disarray, quality and precision of your medical products need to be a top priority. Because in medical device manufacturing, there is simply no room for shortcuts.
The Future of Instruments for Minimally Invasive Surgery
What are the areas of innovation that will continue to further advance minimally invasive surgery as the operating method of choice? In this article, we take a look at some of the future developments we look forward to seeing.
Advancements in Today’s Electronic Medical Device Industry
Advancements in mobile technologies, flexible circuits, microelectronics, and embedded systems have played a major role in the emergence of novel medical devices and healthcare solutions. So what are the most significant advancements in today’s electronic medical device industry?
Balloon Catheter Design and Manufacturing
Balloon catheters production requires extensive know how. In this article, we discuss the design considerations, as well as take a look at manufacturing overview of balloon catheters.
How to Conduct an OEM Audit for a Medical Contract Manufacturer
Conducting a medical device manufacturer audit, includes a multitude of items to examine. Especially when considering the gamut of OEM activities: from simpler manufacturing operations, to vertical production facilities. In this article we cover the most important items to consider, as well as some additional factors that demonstrate above average OEM operations.
Case Study: Medical Device Packaging Considerations
Packaging is an often neglected aspect of medical device design. Depending on the case, packaging can have a significant impact on a medical device’s user experience, practicality, cost, and overall success.
Cardiovascular Medical Devices: The Latest Innovations
In this article, we take a look at some of these latest innovations in cardiovascular medical devices.
EU MDR 2020: What to Expect
The EU MDR allowed a 3-year transition period for medical device manufacturers to comply. This runway ends in May 2020, where after the EU MDR comes into full effect. After this point, every part of the medical device supply chain from manufacturers to importers and distributors in the EU, will be required to comply.
Medical Product Outsourcing VS. In-House Manufacturing
Medical Product Outsourcing VS. In-House Manufacturing
The OEM Medical Device and Contract Manufacturer Relationship
Top medical device contract manufacturers have the ability to provide comprehensive services for their OEM partners. In this article we take look at how those attributes can be maximized when a strong and healthy relationship exists.
Trends in Applications and Technologies Used by Catheter Manufacturers Today
In this article we take a look at the applications and technologies that medical device manufacturers use today, to meet the demanding conditions of catheter manufacturing.
Quasar Excited to Announce Expansion of Services to Partners in China
A groundbreaking Chinese government policy change in August 2019 by the National Medical Products Administration (NMPA) will now grant any CFDA registered Contract Manufacturer the opportunity to become a Product Registered Manufacturing Contractor in China. Quasar is positioned to expand its abilities to manufacture, obtain necessary cross regional licensing, and participate as a government approved fully licensed registrant.
Medical Device Contract Manufacturing: How to Find the Right Fit for My Product?
In this article we look into why it’s important to find the right medical device contract manufacturer, as well as important factors to consider in your selection.
How to Conduct FMEA for Disposable Medical Device
FMEA, a method that helps medical device manufacturers identify, break down, control and review the risks associated with product development and manufacturing.
When is a Quality Management System (QMS) needed for Medical Devices?
Medical device companies can experience difficulty determining when to start setting up a Quality Management System (QMS). The time range required to fully establish a QMS is between 3 to 9 months. In this article, we take an overview look of what a QMS is and when you need to have one in place.
Common Mistakes when Transferring Medical Device Manufacturing to High Volume
In the following article we cover some of the common mistakes that are made when transferring medical device manufacturing to high volume. The ability to identify these areas at an early stage together with proper management, can be critical to a medical device’s lifecycle. These common pitfalls that result in costly corrective actions can be avoided altogether.
Case Study: Plastic Molding DFM
Introduction It’s not uncommon for companies to seek a device manufacturer after having completed the prototype development phase. That’s because they mistakenly assume that the product development team has manufacturability in mind. On the contrary, however, experience shows that during development, engineers will focus on design outputs to meet the design inputs. And not enough focus goes into product manufacturability as is necessary. It is absolutely critical to involve the device manufacturer from early on in the design phase. Otherwise, companies run the risk of developing products that will have issues with manufacturability that pose serious challenges in later stages. This study [...]
Q&A: All you Need to Know About the New EU Medical Device Regulation (MDR)
This article is a brief summary in the form of a Q&A, about the key changes and most important points of the new EU medical device regulation.
FDA Medical Device Classification: Process Explained
In this article we outline the FDA medical device classification process.
The Quasar team looks forward to seeing you at BIOMEDevice
Let’s find a time to meet and discuss how we can help with your product. We are exited to showcase our special abilities in contract manufacturing for medical devices with companies in all stages of the product cycle in the great city of Boston. Booth #229
5 Things You Need to Know about the Israeli Medical Device Industry Today
Israel is considered to be amongst the world leaders in the field of medical devices. The total number of granted patents in the area of medical devices, positions Israel at the first place in the world in patents per capita, and in the fourth place in terms of absolute number of patents.
The Golden Path Towards Mass Production
Quasar partners with MedNet GmbH, a Germany-based, international service provider for the medical contract manufacturing industry.
Why ISO 13485 Might Not Be Enough for Your Medical Device Manufacturing Process
ISO 13485 manufacturing is an established quality standard, pertaining to medical device manufacturers. However, as with any quality standard, it is more a set of general guidelines which every manufacturer applies to their own situation according to their status, infrastructure, and working conditions, rather than a recipe for success. There are multiple ways in which it can be applied to each manufacturer’s case, therefore making each medical device manufacturer responsible for guaranteeing their operational effectiveness and success, independent of their ISO 13485 manufacturing certification. An Overview Of ISO 13485 Manufacturing Quality Standard First published in 1996, ISO 13485 in manufacturing is [...]
A Simplified Introduction to Medical Device Design Control
Often, when working on developing a medical device and its design control, designers and engineers find themselves stuck or having to repeat the same processes, again and again, to fix and perfect their design. Considering these seven common steps for design and control of medical devices can help a team avoid some of the most common pitfalls. Since 1990 and 1993, the US (21 CFR 820.30) and EU (MDD 93/42/EEC) respectively included Medical Devices in their GMP (Good Manufacturing Practices) set of rules and regulations, with the International Standards Organization (ISO) following suit in 1996 by publishing their voluntary ISO [...]
The Four Phases of Medical Device Product Development Lifecycle
The Four Phases of Medical Device Product Development Lifecycle 1. Conception This phase contains several steps from idea conception, the use context of the medical device, initial concept development, up to proof of concept. These ideation processes generate abstract concepts in need of further development, refinement, and adaptation, to result in a workable base for developing a medical device that is effective to use, feasible to produce, and can achieve regulatory compliance. 2. Design & Development New Process Development (NPD) Medical device product design should be carried out with manufacturing in mind. From the early stages of device components design, factors such as practical [...]
The Secret Sauce to high quality
The Secret Sauce to high quality: Preventative Quality Processes and Sisyphean Improvement Cycles. Preventive quality processes and Sisyphean Improvement Cycles are the secret sauce to winning your market. Do you have them built into your production process?