Preparing for MDR: Don’t Forget about Class I Reusable Devices
Learn about the new subclass for Class I reusable devices under MDR and the necessary steps to ensure compliance.
Tag Archives: EU MDR
Keep Calm and Carry On… And Other Outlooks We Can Apply to MDR Implementation
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
EU MDR: What We Can Learn from Other Professions
From farming to teaching to firefighting, there are many principles of non-medtech professions that can be applied to EU MDR implementation.
Breathe Easy on CERs
The first critical step in being able to feel confident about your clinical evaluation reports (CERs) is to ensure you know exactly what they entail.
Best of 2018 in MedTech
Here are the most read articles of the year.
EU MDR Post-Market Surveillance: Active, Integrated, Risk-Based, and Planned
Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
First Step in EU MDR Compliance: The Gap Analysis
A gap assessment provides a toolbox for the decision-making process.
Misconceptions of EU MDR Implementation
Lack of preparation and understanding of the efforts required to comply with the regulation will hinder product launches, negatively impact sales, and hurt a company’s reputation.
How to Plan for EU MDR So You Can Sleep at Night
Learn about the implications of changes to ISO 10993-1 and the introduction of the MDR, stages of pre-clinical device testing, why chemical characterization is more important than ever before, and how device manufacturers can begin assembling the right team of testing experts to ensure their products are safe and ready for market.
Most Popular Stories: It’s All About EU MDR
The readers of MedTech Intelligence continue to crave any content that will help them learn more about the Medical Device Regulation.
