Regulatory Affairs

We are a progressive FDA registered, medical device company with a quality system in compliance with Government Regulation 21 CFR Part 820, Quality System Regulation, and a certified ISO 13485:2003 company. The Total Quality Management (TQM) of the company provides its customers with consistently high quality products.

All employees are given comprehensive training on the requirements of the Quality System Regulation (QSR) and all aspects of Good Manufacturing Practices (GMP) prior to their first work assignment.

Our customers are encouraged to review The PMP Quality Manual and are invited to visit and conduct compliance audits at Precision Medical Products. We will assist our customers with all of their regulatory requirements.