Innovative Approaches

3:15 pm – 5:30 pm Innovative Approaches for Postmarket Evaluation: At the Cutting Edge

3.15 pm  Contemporary postmarket for medical devices MDEpiNet-   DanicaMDEpiNet Danica

3:45 pm  IDEALpm IDEAL recommendations for Stage 4 (TBD- IDEAL UK)

4:15 pm  Structuredpm Structured small group discussion of post-market
[organized into stakeholders groups: FDA/regulatory, IDEAL, industry, users].

Points to discuss

  • Desirable characteristics of robust system
  • Strengths and Weaknesses of current system
  • Strengths and weaknesses of IDEAL recommendations
  • Barriers to change

[Moderator to ensure discussion touches on each point and recorder summarizes agreement and disagreement]
5:00 pm Report from groups [each group facilitator/chairperson presents on behalf of group]

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