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  How Minimum Viable Products Deliver the Most Valuable Products (MVP) for Medical Device Development

  Achieve more accurate budgeting in medical device development by clearly defining the intent of the Minimum Viable Product (MVP).

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  FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions

  Review of April 2023 FDA draft guidance on PCCP Recommendations for AI/ML-Enabled Device Software Functions.

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  FDA Action Plan for AI/ML in SaMD (Software as a Medical Device)

  Overview of the FDA action plan for AI/ML in software as a medical device (SaMD) and list of best practices.

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  Cleanroom Validation Testing for Medical Device Manufacturing

  Overview of Cleanroom Validation Testing for Medical Device Manufacturing Cleanrooms based upon actual Toronto facility experience.

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  Qualifying and Managing RoHS and REACH suppliers

  RoHS and REACH compliance is required to sell equipment or consumer parts with hazardous materials in EU, China, Korea, United States and Canada.

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