POLICY & REGULATION COMMERCIAL R&D An update on NEST real-world Mark Hitchman of Canon Medical Two firms nab US breakthrough evidence efforts, p. 6 Systems discusses market growth status, p. 22 strategies, p. 15 Medtech Issue 80 Pharma Intelligence Informa February 5, 2018 medtech.pharmaintelligence.informa.comInsight 'WE SURVIVED MDSAP': The final visit from the US agency that year was the last straw, she said. "That FDA inspection really made me Cynosure Aces Single-Audit Program want to get Cynosure involved in MDSAP because I cancelled a vacation to Indonesia Twice; Tells How Your Firm Can, Too to stay behind for that inspection," Hoy said. "That's when I learned that travel insurance SHAWN M. SCHMITT
[email protected] doesn't consider an FDA inspection to be an emergency that's reimbursable." MDSAP , created by the International Medical Device Regulators Forum (IMDRF), allows firms to undergo only one audit by an accredited third party to satisfy quality regulations for five countries: the US, Can- ada, Brazil, Japan and Australia. The program runs on a three-year cycle, albeit with differing scopes for each audit. Firms are certified to MDSAP in the first year; in the second and third years, they submit to surveillance audits, which are typically quicker than a certification audit. The cycle then repeats, with recertification to MDSAP Shutterstock: alphaspirit Shutterstock: occurring in the fourth year, and so on. MDSAP ran as a pilot program for three or longtime quality and regulatory "It was particularly difficult that year to full years from January 2014 through expert Connie Hoy, the decision to be in the quality department at Cynosure December 2016, but is now a bona-fide F ditch the prying eyes of multiple because all we did was get audited.