Pharmaceutical companies have long been subject to the kinds of rigorous electronic reporting standards that will soon affect medical device manufacturers. What can be gleaned from their experiences?
The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.
Learn about the new subclass for Class I reusable devices under MDR and the necessary steps to ensure compliance.
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.
From farming to teaching to firefighting, there are many principles of non-medtech professions that can be applied to EU MDR implementation.
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.
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Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
A gap assessment provides a toolbox for the decision-making process.
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.