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The up-classification of devices under the new EU MDR has definitely put some manufacturers in a very difficult ...
The new EU Medical Device Regulation (MDR) was published in the Official Journal of the European Union on May 5, ...
ISO 13485:2016 emphasizes a risk-based approach to the entire QMS, shifting from the traditional risk approach ...
For manufacturers of medical devices, it can be an easy trap to fall into only focusing on the compliance of your ...
The new European Medical Device Regulations and the In Vitro Diagnostic Devices regulation have a lot emphasis on ...
One of the major changes with the EU MDR that medical device manufacturers will feel as they transition to comply ...
Companies are often in doubt about outsourcing Internal Audits especially when they have an in-house quality ...
If you are developing a medical device, you will need to become familiar with Design Controls. 21 CFR 820.30 ...
Complaint handling can be a daunting task especially if you are a small company. 21CFR 820 requires customer ...
Do you have a medical device that treats or diagnoses a life-threatening disease? If yes, your device may be ...
As a medical device manufacturer, every company must establish a QMS in compliance with 21CFR 820 (if you sell in ...
The process of creating, manufacturing, and marketing a medical device can be extremely difficult to navigate. ...
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