Take the ISO 13485 course exam and get the ISO 9001 course exam for free
LIMITED-TIME OFFER – VALID UNTIL SEPTEMBER 30, 2021

Expert Advice Community

Guest

Requirements for SAMD

  Quote
Guest
Guest user Created:   Mar 18, 2021 Last commented:   Mar 19, 2021

Requirements for SAMD

I am looking for some help on Health Canada requirements for SAMD ( software as Medical Device) for a Dental radiology software. I feel it is classified as class II.

Please let me know if you have any knowledge on this- which clauses of ISO 13485 can be excluded>

0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Mar 19, 2021

Classification of software is covered in the MDR by Rule 11.

"Software intended to provide information which is used to make decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

  • death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or
  • a serious deterioration of a person’s state of health or surgical intervention, in which case it is classified as class IIb.

Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

All other software is classified as class I“

In my opinion, it is class IIb – because if the software is wrong, and the dental doctor receives the wrong picture, there can be conducted a wrong surgical intervention.

For software, the following requirements from the ISO 13485:2016 standard are definitely not applicable:

  • 7.5.5 Particular requirements for sterile medical devices
  • 7.5.7 Particular requirements for validation of a process for sterilization and sterile barrier systems
  • 7.5.9.2 Particular requirements for implantable medical devices

Following requirements have to be taken into consideration:

  • 7.5.3 Installation activities
  • 7.5.4 Service activities

All requirements that are not applicable must be stated in the Quality manual with justification why those are not applicable.

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Mar 18, 2021

Mar 19, 2021