A high number of complaints is not necessarily indicative of poor device quality. There could be many reasons for large number of complaints. Customers may be dissatisfied when they have expectations beyond the capability of what a device can do. There could be a requirements mismatch. A manufacturer may have return policies that inadvertently encourage […]
Month: July 2022
EU MDR PRRC… Let me explain!
The EU Medical Device Regulation (MDR) requires manufacturers to have available at least one person, within their organization, responsible for Regulatory Compliance. That person is known as Person Responsible for Regulatory Compliance or PRRC (we love acronyms!). For a Micro and/or small enterprise, the PPRC does not need to be within the manufacturer’s organization but must […]