The Importance of Human Factors in Device Design
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 optimizing user experiences. The discipline of Human factors engineering (HFE) focuses on the interactions between people and systems, aiming to optimize product design to improve usability, performance, and safety. In […]
The Strategic Role of Combination Products in Disease Treatment
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 Architects® Combination products integrating drugs or biologicals with medical devices are revolutionizing the treatment landscape for various diseases. By combining the therapeutic benefits of multiple components into a single, cohesive […]
EU MDR Article 18: Important Changes, Dates, and Challenges
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 European Union Medical Device Regulation (EU MDR), which replaced the Medical Device Directive (MDD) in May 2017, has significantly impacted the industry. Compliance with the EU MDR is essential for […]
EU MDR Implementation: Important Dates and Challenges
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, which replaced the Medical Device Directive (MDD) in May 2017, is essential for selling medical devices in the EU. Key Aspects of the EU MDR Implementation Governing Production and Sale: […]
Meet the Awesome Medical Device Team at Compliance Architects
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 heart of our success, and today, we’re excited to introduce you to some exceptional individuals who bring their expertise to the medical device industry. Let’s dive in and get to […]
