by PsyphaDeejay | May 12, 2020 | Archived, ISO13485, Uncategorised
We’ve been working with companies in the medical device market for over ten years. Gaining approval to ISO 13485, (the quality system standard required for by a medical device business) isn’t easy. It often takes over a year from start to certification for even...
by PsyphaDeejay | Mar 12, 2013 | Archived, General, ISO13485, ISO14971, Medical Device Certification
I’m going to begin with what would normally be my closing comment, that is, there is much, much more to expand on in the whole area of medical device certification, compliance with Medical Devices Directive, with ISO 13485, and ISO14971, etc, etc. What you read...