'We Survived MDSAP': Cynosure Aces Single-Audit Program Twice; Tells How Your Firm Can, Too
Executive Summary
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.
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