Cypress in medical device?

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user_4688661
Level 1
Level 1

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
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1 Solution
Rakshith
Moderator
Moderator
Moderator
250 likes received 1000 replies posted 750 replies posted

Hello user_4688661​,

You can refer to the PSoC Creator User Guide for information regarding PSoC Creator, Generated Source, etc. PSoC Creator is IEC 9899 compliant and the deviations are mentioned in the User Guide as well. Let me check internally if PSoC Creator is validated for IEC 62304.

You can refer to the PSoC Creator Release Notes for the known issues with the corresponding release version of PSoC Creator.

Thanks and Regards,

Rakshith M B

Thanks and Regards,
Rakshith M B

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2 Replies
Rakshith
Moderator
Moderator
Moderator
250 likes received 1000 replies posted 750 replies posted

Hello user_4688661​,

You can refer to the PSoC Creator User Guide for information regarding PSoC Creator, Generated Source, etc. PSoC Creator is IEC 9899 compliant and the deviations are mentioned in the User Guide as well. Let me check internally if PSoC Creator is validated for IEC 62304.

You can refer to the PSoC Creator Release Notes for the known issues with the corresponding release version of PSoC Creator.

Thanks and Regards,

Rakshith M B

Thanks and Regards,
Rakshith M B
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Rakshith
Moderator
Moderator
Moderator
250 likes received 1000 replies posted 750 replies posted

Hello user_4688661,

I received an update from the internal team and PSoC Creator is not validated for IEC 62304.

Thanks and Regards,

Rakshith M B

Thanks and Regards,
Rakshith M B
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