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

This medical device webinar will discuss 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.

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