Cook Medical to collaborate on Medical Device Single Audit Program

Cook Medical has welcomed the introduction of the new Medical Device Single Audit Program (MDSAP), a new means of auditing and monitoring medical device manufacturing for patient safety.

The firm is one of the global medical device companies that has agreed to collaborate internationally with regulatory authorities on this scheme, with the Cook Medical plant in Limerick, Ireland, chosen to trial this new auditing approach.

It underwent a two-day initial certification audit in April and is the first Irish site to take part in MDSAP, with the audit being one of six to have taken place globally to date.

The MDSAP enables regulatory oversight of manufacturers' quality management systems, while promoting more efficient and flexible use of regulatory resources and leveraging existing conformity assessment structures where appropriate.

Pete Yonkman, president of Cook Medical, said: "This progressive approach to regulatory oversight is very exciting. We recognise that good collaboration among regulatory agencies and industry enables more efficient and flexible use of both regulatory and company resources."

The firm expanded its product range with the launch of its new Hercules 100 oesophageal dilation balloon, for use in oral or transnasal oesophagoscopy procedures, earlier this month.