Cook Medical’s Irish Plant to Participate in MDSAP
Cook Medical announced Friday it will collaborate with regulatory authorities on the Medical Device Single Audit Program, a global program to audit and monitor medical device manufacturing for patient safety.
The MDSAP allows for regulatory oversight of manufacturers’ quality management systems while minimizing the regulatory burden on industry. It promotes efficient and flexible use of regulatory resources through work sharing and mutual acceptance among regulators while respecting the authority of each agency.
Cook’s Limerick, Ireland, plant was chosen for the new auditing approach, making it the first Irish facility to do so and becoming one of the first six global MDSAP audits to date. The site underwent a two-day initial certification audit in April.
The MDSAP is based on a three-year audit cycle, with initial certification audits performed, followed by a partial surveillance audit each of the next two years and a complete recertification audit after three.
The organizations that make up MDSAP include the FDA, Health Canada, Australia’s Therapeutics Goods Administration, ANVISA in Brazil and Japan’s Ministry of Health, Labor and Welfare and the PMDA. — Kellen Owings