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2014

Most recent regulatory developments: Medical Device Single Audit Program (MDSAP) and EU Enforcement of Unannounced Audits.

The first part of the presentation will focus on the most immediate impact on Industry from International Medical Device Regulatory Forum (IMDRF) – the Medical Device Single Audit Program (MDSAP), one audit serving many regulations. Learn about the MDSAP for the US, Canada, Brazil and Australia. Since May 2014, authorities of these countries have been appointing audit organizations for the MDSAP program. In the future, MDSAP certificates will replace regular audits from the named authorities.

The second part of the presentation will focus on new product sampling and testing requirements associated with unannounced audits and offer suggestions for ways manufacturers can prepare and train in advance. In response to the EU Commission Recommendation on 24 September 2013 (2013/473/EU), Notified Bodies must implement unannounced visits to CE-certified manufacturers, sub-contractors and/or crucial suppliers.


Mr. Harshit Thakkar
Project Manager

DEKRA Certification B.V., USA

Mr. Harshit Thakkar is a Project Manager for DEKRA Certification B.V. in Chalfont, PA, USA. Mr. Thakkar is a lead auditor for CE and ISO 13485:2003 audits (including CMDCAS) and also performs Technical File and Design Dossier reviews for manufacturer’s seeking CE marking for non-active and active medical devices. Mr. Thakkar has seven years of experience working in the medical device industry in the field of engineering, quality and regulatory affairs. Mr. Thakkar holds a Masters Degree in Biomedical Engineering from University of Southern California, Los Angeles, USA and Bachelors in Biomedical Engineering from D. J. Sanghvi College of Engineering, Mumbai, India..