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Complimentary Webinar

August 20, 2020 | 1:00 p.m. - 2:00 p.m. ET

2021 - Preparing for Changes in the EU MDR Complaint Management and Vigilance Regulations

Regulators are increasingly turning their attention to post-market regulations. Evidence can be seen in the new EU Medical Device Regulation, changes in ISO 13485:2016, and FDA guidance.

Since the publication of EU MEDDEV 2.12-1, there should be no surprise that the vigilance requirements in the new EU MDR share a lot of similarities. However, there are a few important changes, not really new, but rather bringing the EU legislation up to date. Although the May 2020 date has been postponed a year, this doesn’t mean you have more time to wait. Medical device manufacturers need to ensure that their procedures are updated NOW and employees responsible for vigilance reporting are trained on all the changes.

Learning Objectives:

Whether you are a manufacturer, an authorized representative, an importer, a distributor, a user or a health professional, this webinar will help you understand what you need to know about the definitions, terminology, reporting timeframes and other changes for assuring compliance with EU-MDR/IVDR vigilance regulations.

What stays the same? What is changing?
Impact from MEDDEV 2.12-1 Rev 8
New MIR form terminology/coding harmonization and UDI
Role of risk management and CAPA in effective complaint handling
Supporting multiple countries – differences to US FDA regulations and processes
Preparing for MDSAP audit of your complaint handling system

Who Should Attend:

Quality Personnel
Regulatory Personnel
Post Market Surveillance Personnel

SPEAKERS

Michele B. Donatich
Independent QRA Consultant
at Michele B. Donatich

Ms. Donatich has a proven track record of successfully contributing to the Quality and Regulatory Department within the Cardinal Health Medical Organization for twenty-five years. During that time, she had roles of increasing responsibility within the organization focusing on Customer Advocacy and Quality Management.

Ms. Donatich received her RN from The College of Staten Island in 1974 and attended the University of Laverne in California, where she completed studies in HealthCare Management (BSHCM, 1993). Her nursing experience was primarily critical care focused, working predominately in ICCU/CCU/ER and Telemetry units for over twenty years. She ended her Nursing career as the Director of Critical Care in a 391 bed Trauma 1 facility in Los Angeles before joining Baxter Healthcare, in 1990. She started working in Baxter, as a Sr. Clinical Specialist in the Respiratory product line and continued to work through the many mergers and company acquisitions which followed, including Cardinal Health in 1999.

Ms. Donatich was the Director of the Customer Advocacy Department for which had responsibility for the management of customer issues for the Medical organization, as well as, the coordination of all field corrective actions, for any self-manufactured and distributed products sold by Cardinal Health, a Fortune 20 Drug Wholesaler and Medical Supplier.

Maria Fontanazza
Editor-in-Chief
MedTechIntelligence.com

Maria has more than 15 years of experience in journalism, marketing, and communications. She was previously marketing communications manager and market research manager at Secant Medical, Inc., a manufacturer of biomedical textiles and advanced biomaterials. Maria also served as an editor at MD+DI and has authored articles that have appeared in domestic and international industry publications. She has a B.A. in Journalism and Mass Communications with a concentration in New Media and Visual Design, and a Minor in Fine Arts, from St. Michael’s College in Colchester, VT.

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