Medical Device and Combination Products

Given the pace of innovation in the medical device industry and device design, understanding the role of human factors is crucial for ensuring safety and

Is it or is it not a Combination Product? by. Pedro Martinez, VP and Subject Matter Expert, and Teresa Gorecki, VP and Practice Lead Compliance

In my previous article, EU MDR Implementation: Important Dates and Challenges, we examined the effects of the new EU MDR on medical device manufacturers. The

The implementation European Union Medical Device Regulation (EU MDR) has had a profound impact on the medical device industry. Compliance with this EU MDR implementation,

At Compliance Architects LLC, we don’t just provide top-notch quality compliance solutions; we celebrate the people who make these services possible. Our team is the