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Device Firms Invited To Join MDSAP Ahead Of 2017 Full Launch

Executive Summary

Medical device firms are being invited to participate in the international single audit program, which will enter the operational phase next year.

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More Manufacturers Sign Up For Single Audits As MDSAP Becomes Operational

A growing number of medtech manufacturers have expressed interest in the Medical Device Single Audit Program since MDSAP became fully operational in January. The program has also drawn interest from regulatory agencies beyond those from the five participating countries, and a policy is being framed to admit new members.

Canadian Medtech Keeps An Eye On Transition To MDSAP; Regulator Won't Allow Grace Period

As Health Canada prepares to kick-start in 2017 its two-year plan to fully adopt the Medical Device Single Audit Program (MDSAP) in place of the current Canadian Medical Devices Conformity Assessment System (CMDCAS), the local medtech industry association MEDEC is upbeat about the change and says that while the transition plan may pose challenges, it believes it is too early to say what these might be1,2.

ISO 13485 Update: Worries About Firms Missing 2019 Deadline; Quality Systems Standard Handbook In The Works; Suppliers Now Eligible For Certs – And More

Device manufacturers might be tempted to put off becoming certified to the newly revised ISO 13485 because they've been given three years to conform to the global quality systems standard. But not so fast, says ex-FDA official Kim Trautman, who's worried that ISO's three-year window for companies to comply will "lull people into a false sense of security": "Not every firm has three years, per se, to transition from the 2003 version of ISO 13485 to the 2016 version; some firms might only have one year depending on how their certifications are laid out," she warns. Meanwhile, ISO is authoring a handbook to the revised standard, and Trautman talks about what firms should keep an eye on in the rejiggered standard, including its scope – which now allows vendors to be certified to the standard – and sections on compliant handling, purchasing activities and risk. Also: a podcast interview with Trautman, who talks about her worries that firms will miss ISO's March 2019 deadline.


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