The year 2021 has brought with it a host of changes in addition to dealing with the ongoing pandemic, such as the EU MDR update that went into effect in January 2021. The update of the FDA QSR to match more completely with the ISO 13485; and the FDA 21 CFR Part 820.
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.
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.
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
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
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.
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.
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.
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.
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.
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.