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Marion Lepmets
Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11, deals with the requirements for Electronic Records and Electronic Signatures to be considered “trustworthy” by the FDA. If you work in the MedTech or Pharma sector, you probably have heard about this regulation plenty...
Marion Lepmets
Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11, deals with the requirements for Electronic Records and Electronic Signatures to be considered “trustworthy” by the FDA. If you work in the MedTech or Pharma sector, you probably have heard about this regulation plenty...
Marion Lepmets
Marion Lepmets
In the Medical Device industry software components, whether standalone or as part of a physical device, must follow the same rules as any other component, i.e. ISO 14971 “Medical devices – Application of risk management to medical devices”. BUT .. but there are significant deviations required by IEC 62304 and...
Marion Lepmets
Your software is likely to contain a number of components, items, packages, libraries, etc. not developed directly by your company. It may include open-source or purchased software. Unless you have a very close relationship with the developer and access to the source code, these components are black boxes for you....
