Overall, MDSAP will reduce the time and resources required for audits and inspections, and aid in international trade.
When it comes to compliance, the FDA does not grant special dispensation.
Know how IQ, OQ and PQ—the three essential elements of a Quality Assurance System—govern the medtech sector.
Failure to investigate complaints is a major compliance failure.
Part II of the ISO 13485 IQ test digs a little bit deeper into the standard.
An adequate structure must be in place to support a QMS.
A review of changes made to the standard published earlier this year.
How to prepare for a successful transition.
If you climb into FDA’s sandbox, be prepared to play by the rules.
You need a management representative with oversight over medical device quality.