Writing Effective Clinical Evaluation Reports as Part of Post-Market Surveillance

Why Should You Attend:

Post Market Surveillance is a critical area in marketing medical devices and has gained tighter scrutiny by regulatory agencies over the past several years. Having appropriate and effective post market surveillance processes in place can help one avoid costly and embarrassing product recalls by being proactive rather than reactive.

During this interactive webinar training, the speaker, a highly experienced regulatory affairs and quality assurance professional, will cover strategies for meeting the Post Market Surveillance requirements as described in Annex X of the MDD (MDD 93/42/EEC, updated per the 2007/47/EEC M5 amendment, Annex 1: Essential Requirements), MEDDEV 2.7.1, Dec 2009 and ISO 14155.

Learning Objectives:

Upon completion of this session, attendees will understand key benefits to implementing and maintaining an effective post market surveillance process as well as the associated regulatory requirements. Attendees will also gain a basis for evaluation of existing post market surveillance processes and implementation of improvements or new processes.

Areas Covered in the Webinar:

• Describe the primary benefits of implementing and maintaining effective post market surveillance.
• Review the requirements of post market surveillance.
• Introduce a methodology for evaluating existing post market surveillance processes.
• Outline implementation of an effective post market surveillance process.
• Elements of an effective post market surveillance process.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Medical device QA managers
• Regulatory affairs professionals
• Clinical managers or project managers
• Medical device product development managers or project managers
• Documentation
• Marketing

Instructor Profile:

Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.

Cheryl is a member of Regulatory Affairs Professionals (RAPS), Association for the Advancement of Medical Instrumentation (AAMI), Medical Device Manufacturers (MDMA) FDA Working Group, and the MDMA Compliance Working Group. She completed the RAPS Executive Development Program at the Kellogg School of Management. She also presented “Develop a Publication Strategy with KOLs during Clinical Development” at CBI’s 8th Annual Forum on Interactions with Thought Leaders and Key Opinion Leaders (KOLs) as well as served as a panelist for “Transparency Strategies and Their Impact on Relationships with Thought Leaders”.

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