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2020 - FDA's Medical Device Software Regulation Strategy

Date2020-11-19 - 2020-11-20


VenueBoston, MA, USA - United States USA - United States

KeywordsSeminar by Ex-FDA Official; FDA mobile apps regulation; Proprietary software


Topics/Call fo Papers

Understanding FDA legal authority
Applying FDA classifications / risk controls
Understanding FDA and NIST software guidance
Identifying the quality system regulation for risk management, software verification and validation
Identifying cybersecurity issues and developing a planned response
Identifying and resolving interoperability issues
Figuring out the scope of FDA’s mobile apps regulation
Learning about bug updates classified as recalls by FDA
Future device software applications

Last modified: 2020-02-14 23:22:57