Medical Device Development: Anticipating and Avoiding Regulatory & Compliance Pitfalls

Pre-Recorded CD Webinar
Approximately 90 minutes in length, Self Examination and Answer Key Included

Who Will Benefit
This training solution will benefit medical device professionals in departments such as Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing/Operations, Research and Development, Legal Affairs

Course Description
Regulatory and compliance hurdles represent a significant risk to new product introduction and could result in a devastating impact to your company’s business interests if not anticipated and addressed from the start of product development. These risks include the delay or halt of product introduction as well as potential civil and criminal penalties for the organization and/or individuals involved. This webinar presentation will provide a summary of these regulatory and compliance hurdles, illustrated with real life examples, and include a discussion of ways to anticipate and avoid them.


  • What are the regulatory and compliance hurdles that are encountered during medical device product development and how do I avoid them?
  • How do these hurdles impact Market Access for the product under development?
  • What are the Design Control Hurdles and how do I avoid them?
  • How do I prepare for Pre-market Approval Inspections (PAI)?
  • What are the risks, both for the organization and for individuals, associated with regulatory and compliance hurdles?
  • What are my next steps to assure compliance with regulatory requirements and avoid the negative consequences of a lack of compliance?

Order On-Line to Own This CD Webinar: $195.00