2021 - FDA's Medical Device Software Regulation Strategy
Date2021-06-10 - 2021-06-11
Deadline2021-05-31
VenueVirtual Seminar, USA - United States
KeywordsFda software regulation; Fda software as medical device; Software as medical device
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
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
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- Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
- Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry (Focus: Brazil, Mexico, Argentina)
Last modified: 2021-05-17 03:46:05