Recording
Recording

Topic 1: ISO 13485 – MEDICAL DEVICE QUALITY MANAGEMENT SYSTEMS Topic 2: 3-HOUR VIRTUAL SEMINAR ON 510(K) AND PMA SUBMISSIONS PROCESS


$988 
  • SKU: MDPACK74

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TOPIC 1: ISO 13485 – MEDICAL DEVICE QUALITY MANAGEMENT SYSTEMS

Areas Covered in the Session :

  • Overview/basic elements of the quality management system
  • Typical quality system elements
  • Key attributes of a functional quality system
  • QSR vs ISO Compliance
  • ISO 13485 content overview and evolution of revisions
  • Implementing your quality system in conformance with the standard


TOPIC 2: 3-HOUR VIRTUAL SEMINAR ON 510(K) AND PMA SUBMISSIONS PROCESS

Areas Covered:

  • 510(k) and PMA processes
  • Current EU Regulatory Requirements
  • Improving Content and Submission Quality
  • CE Marking 
  • Medical Device Classifications
  • IDEs, HUDs
  • Quality system certification
  • Product certification
  • Technical files and dossiers
  • Common Pitfalls and How to Prevent Them
  • What to Ensure While Preparing for an Application
  • Do’s and Don’ts

Course Director: CHARLES H PAUL

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.