regulatory developments: Medical Device Single Audit Program
(MDSAP) and EU Enforcement of Unannounced Audits.
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.
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.
DEKRA Certification B.V., USA
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,