POST – MARKET CLINICAL FOLLOW-UP REQUIREMENTS:
This webinar will help you understand the European Medical Device post market clinical follow up requirements for CE Marking.
Enforcement of the post market clinical follow up (PMCF) requirement is expected to be an area of focus when the upcoming proposed European regulations are approved. In this 30 minute webinar, Rob Packard, subject matter expert and founder of Medical Device Academy, reviews how you can begin to prepare for enforcement. Topics include:
- What is Post Market Clinical Follow Up (PMCF)?
- PMCF purpose
- PMCF current European requirements
- Why will PMCF be required?
- Proposed EU regulations
- Common Technical Specification (CTS) defined
- Post Market Surveillance (PMS) plan
- Integrating PMS and PMCF with risk
- Is PMCF required indefinitely?
- MEDDEV Guidance Document 2.12/2 Rev 2
- How to prepare for enforcement
This webinar package consists of a webinar recording in .mov format and the native PowerPoint slide deck. Upon purchasing the webinar you will receive an email with a link for downloading the content.
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
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About Your Instructor
Robert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.