Computers - IT

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  • FDA's Medical Device Software Regulation Strategy

    FDA's Medical Device Software Regulation Strategy

    Computers - IT Virtual Seminar (california) October 28, 2020 Check with publisher

    The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjun...

  • 21 CFR Part 11 compliance for software validation, data integrity and SaaS/Cloud Seminar 2018

    21 CFR Part 11 compliance for software validation, data integrity and SaaS/Cloud Seminar 2018

    Computers - IT Zurich (Zurich) July 5, 2018 Check with publisher

    Agenda: Day 1 Schedule Lecture 1: Introduction to the FDA How the regulations help your company to be successful Which data and systems are subject to Part 11 Lecture 2: 21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures What ...