change control

How to Create an Efficient Change Control Board Process

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.

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medical device materials

5 Considerations When Selecting Medical Device Materials for Your Product

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.

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Medical device testing

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.

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medical device electronics

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?

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OEM Audit

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.

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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.

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