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2020 - FDA's Medical Device Software Regulation Strategy
Date2020-11-19 - 2020-11-20
Deadline2020-11-09
VenueBoston, MA, 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
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
Other CFPs
- Risk Management in Medical Devices Industry
- Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
- Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection
- Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
- Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection
Last modified: 2020-02-14 23:22:57