In addition to the regulatory requirement, post-market surveillance offers an opportunity for collecting market data that can provide valuable insight into the device improvement. In this article, we cover some of the tremendous value that can be created both on the business side and the engineering side when post-market surveillance is done correctly for your medical device.
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.
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.
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.
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.
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.
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 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 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.
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.
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.
In this article, we take a look at some of these latest innovations in cardiovascular medical devices.
