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.
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.
The readers of MedTech Intelligence continue to crave any content that will help them learn more about the Medical Device Regulation.
Here’s what companies think when it comes to how much it will cost to comply with the new regulation.
Does your company understand the magnitude of the compliance effort?
The FDA wants to know that rework activities are not impacting product safety and efficacy issues or influencing long-term product reliability.
How manufacturing execution systems not only help with audits but also aid in production efficiency and faster product introduction.
A guide to what to expect during your certification audit and how to prepare.
Following protocols and maintaining compliance have been common themes.
It is one of the most basic of quality requirements.