In the last 3 Months, the amount of interest I've had from my network in regards to MDSAP has really grown. It's gone from clients dropping it into conversation, to calling me to ask about the depth of my candidate base in this area right through to being asked by large manufacturing companies to come and present to their respective boards in regards to market feelings and full on in-depth candidate market availability with regards to MDSAP knowledgeable Contractor/Advisor's. Question is, have we left it too late as an industry? Have we taken it seriously enough? All I can say is that the UK clients who know the most about the changes have made sure to align themselves with the industry leading contractors months ago and the pool of experts is quickly drying up.
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). Beginning in January 2014, FDA will be participating in a MDSAP Pilot alongside other international partners. FDA will accept the MDSAP audit reports as a substitute for routine Agency inspections. The MDSAP Pilot is intended to allow MDSAP recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.