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.

 

Speakers:

·        Mindy McCann, VP Regulatory Compliance US, Qserve

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 aspects.

·        Giovanni Di Rienzo bio, EU MDR Lead, Qserve

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 BSI.

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 of Turin.

The key expertise areas of Giovanni:

·        Expert advice on CE certification and CE strategy for medical devices, including high risk, combination devices and devices containing animal tissue Regulatory advice, set up, preparation or review of technical documentation in support of compliance with the Medical Device Directive 93/42/EEC or the Medical Device Regulations 2017/745
·        Assessment, gap analysis and remediation strategy for Clinical Evaluation Reports and PMCF against the requirements of MEDDEV 2.7/1 rev. 4, MEDDEV 2.12/2 rev. 2 or Medical Device Regulations 2017/745
·        Strategic advice on PMS, PMCF (including PSUR) and clinical evaluations consultations (per art. 54 MDR)
·        Regulatory advice or review of labeling, instructions for use, marketing material and Summary of Safety and Clinical Performance (SSCP)
·        Detailed knowledge of the Medical Device Regulations 2017/745
·        Expert advice on Notified Body selection and interaction
·        Technological/Product expertise in the following areas: vascular and neurovascular stents, surgical and transcatheter heart valves, surgical and transcatheter valve repair devices, cardiac occludes, vascular and cardiovascular catheters (including angioplasty, electrophysiology, CVC's, etc.) emboli protection devices, implantable ports, embolization devices (including embolization beads)

Questions

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