1 Reply Latest reply on Nov 18, 2020 2:25 AM by RakshithM_16

    Cypress in medical device?

    user_4688661

      We intend to use Cypress PSoC Creator 4.3 and CYBLE-214015-01 in a medical device development according to IEC 62304 and FDA guidances.

      The medical device has moderate level of concern (FDA) and software safety class B (IEC 62304).

       

      - Do you have a validated/certified PSoC Creator according to IEC 62304 and FDA guidances?

      - Do you have a basic documentation for the sources generated by PSoC Creator?

      - Do you have a basic documentation for the standard library functions like memcpy, etc.

       

      A basic documentation means an answer to the following questions:

      • Identification of the OTS / SOUP Software
        • Title
        • Manufacturer and Country of Origin
        • Version Level
        • Release Date
        • Patch Number
        • Upgrade Designation
        • Retrieved from
        • Digital Signature or Checksum
      • Reference Documentation
      • Known Bugs
      • Availability as Source Code
      • Access to Updates
      • Hardware and Software Requirements
      • Actions Required by End Users
      • License Information
      • Copyright Information
      • Expected Design Limitations
      • Description of the OTS / SOUP Functions