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'Perfect Storm' Arrives: Clock Ticking For Device Firms To Conform To ISO 13485, MDSAP, EU & ASEAN Regs

Executive Summary

Device manufacturers that haven't begun conforming to various ongoing international regulatory changes are behind the 8-ball and risk noncompliance, industry insider Kim Trautman says.

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'Burn Them Out, Turn Them Over': Add Auditor Exhaustion, 'Boutique' Approach To The List Of Notified Body Challenges

From not enough notified bodies and auditors, to a slew of new or updated international standards and regulations coming into force, the medtech industry is facing a number of NB challenges – and now they can add auditor burnout as a concern. "Because some of these notified bodies have such huge demand, they're burning people out really fast," industry expert Kim Trautman says, noting that device-makers can expect to see "boutique" notified bodies popping up over the coming decade. Also: Johnson & Johnson's regulatory director explains how the dearth of notified bodies and auditors is affecting the global medical products giant.

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

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.

US FDA Inspections & FDARA: Will New Law Light The Way For Investigators? Maybe, Experts Say

The FDA Reauthorization Act, enacted last month, includes provisions that aim to improve FDA's inspection process, including putting a stop to arbitrary audit scheduling by the agency – a practice that can cause a facility inspection to drag on for weeks at a time. FDA has until early 2019 to draft a guidance document that lays out how it will ensure a more uniform inspection process that ensures greater parity between foreign and domestic audits. Steps mandated by the new law include notifying firms in advance of records that will be requested during an inspection and specifying a window of time for investigators to conduct the onsite inspections. But industry experts are of two minds as to whether any substantial changes will result from the new law. Also: FDA device center Director Jeff Shuren weighs in.

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