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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Medical Device manufacturers have all been challenged in
creating Clinical Evaluation Plans (CEP) and updating their EU Clinical
Evaluation Reports (CERs).
Participants will learn the most common findings identified
by Notified Bodies and by Qserve when performing a final CER review to the
requirements of the MDR and MEDDEV 2.7/1 rev.4.
During this webinar some ways to make sure these findings are addressed
prior to review by a Notified Body will be discussed.
Mindy comes to Qserve with more than 15 years of experience
in medical device international Regulatory Affairs. During that time, Mindy
worked for a private medical device manufacturer and two Notified Bodies,
providing expertise in European, Canadian and Australian medical device
regulations and medical device quality management systems.
As the Senior Director of International Regulatory
Compliance at TransMedics, a manufacturer of portable, ex-vivo perfusion and
assessment donor organ transplantation devices, Mindy developed and implemented
regulatory strategies, and worked closely with regulatory authorities and the
executive team to support existing commercial products, new product development
and clinical investigations for markets outside of the USA.
At SGS, Mindy was the Vice President of Health Care in North
America, responsible for the management of the medical device, healthcare and
pharmaceutical and cosmetic auditing certification and medical device CE
certification business. At DEKRA (formally KEMA Quality), Mindy served as the
global Certification Manager and Senior Project Manager where she worked
closely with the Dutch Competent Authority, Notified Bodies, Project Managers,
and medical device manufacturers. Mindy has extensive experience auditing and
performing technical reviews of both high-risk and low-risk medical devices,
having conducted over 200 design dossier/technical file review and over 500
audits. She also conducted extensive training in regulations and future developments.
During her career at the Notified Body, she was technical expert and reviewer
for labeling, risk management, packaging, shelf life, and sterilization
Giovanni has 20 years of experience in the medical devices
field, ten of which have been spent at two major Notified Bodies, TÜV SÜD and
Throughout this period Giovanni assessed over 400 design
dossiers or technical files of high-risk devices in the cardiovascular,
endovascular, and neurovascular field, including drug-device combinations,
absorbable devices and devices containing animal tissue and has overseen the
assessment of many more. He conducted several unannounced audits and QMS
audits, in the role of technical assessor. He was heavily involved in the MDR
project and was a qualified internal and external MDR trainer for TÜV SÜD.
Giovanni has a degree in mechanical engineering from the Polytechnic University
The key expertise areas of Giovanni: