Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
It is one of the most basic of quality requirements.
Think outside of the box and approach your QMS with passion and creativity.
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
Training is not a nice-to-have; it’s a fundamental requirement.
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.