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

Instructor: Cheryl Wagoner
Product ID: 703223
Training Level: Intermediate
  • Duration: 60 Min
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.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Nov-2015

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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”.

Follow us :
Managing Your Complaints and Obstacles in Post-Market Requirements
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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