18 - 19 February, 2020 | Berlin, Germany
Lori-Ann Woodard, Medical Device Director, Compliance Practice at Lachman Consultant Services
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Lori-Ann Woodard


Medical Device Director, Compliance Practice
Lachman Consultant Services

Check out the incredible speaker line-up to see who will be joining Lori-Ann.

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Main Conference Day One

Monday, December 2nd, 0019


11:55 AM Harmonization of Agile Software Development and FDA Medical Device Design Control Requirements for SaMD and Digital Health Software

  •  Coordinate a strategy to develop SaMD and software as part of a medical device or combination product systems in compliance with the FDA Design Control requirements
  •   Explore the 21 CFR 820.30 Design Control requirements and Agile development principles in parallel and uncover the least burdensome approach
  • Understand the importance of having a quality management system and the right resources to support SaMD development and post market maintenance