'We Survived MDSAP': Cynosure Aces Single-Audit Program Twice; Tells How Your Firm Can, Too
• By Shawn M. Schmitt
Connie Hoy, executive VP of clinical development and regulatory affairs for the Westford, Mass.-based device-maker, explains how the firm handled audits at two separate facilities under the Medical Device Single Audit Program. Hoy details how her MDSAP experiences unfolded, from the time she was first notified – "I thought, 'I'm either going back to bed or I better turn my fierce on,' so I turned my fierce on" – to the very end of each audit, when the company was handed a few auditor findings that were easily fixed. "There’s not one company that cannot pass the MDSAP audit," Hoy insists. Check out her valuable tips and advice – and colorful anecdotes – in this feature article.
For longtime quality and regulatory expert Connie Hoy, the decision to ditch the prying eyes of multiple regulator-inspectors for the relative ease of the one-and-you're-done approach of the Medical Device Single Audit Program (MDSAP) was a no-brainer.
The year was 2014, and she was fed up with the sheer number of intrusive, costly and disruptive audits her company had to undergo to prove compliance with a
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