The new European Regulation related to medical devices – as adopted by the European Union (EU) Council on 5 April 2017 – does not provide 3D printing with a specific status, raising questions regarding the regulations applicable to this medical innovation.
Overall, MDSAP will reduce the time and resources required for audits and inspections, and aid in international trade.
Visiting your establishment’s website and reviewing it for compliance issues is not a task that Dr. D routinely sees being performed by quality and regulatory professionals.
It is Dr. D’s humble opinion that the execution of an effective internal audit program falls into the basic blocking and tackling bucket.
Yes, there is a link between Form 483 observations and failing to conduct management reviews.
Failure to investigate complaints is a major compliance failure.
As software becomes more complex and connected, device manufacturers must address more risks.
In Part I of our ISO 13485 test, see how much you know about the basics of the standards.
Getting through the complex maze of regulatory requirements can be an overwhelming process for any medical device company.
A three-part series on quality system remediation and what manufacturers need to do to get through the process.