Friday, June 25, 2021

Which software is compliant with ISO 13485 (Medical devices)?

The standard ISO 13485 in his latest version from 2016, ISO 13485:2016 defines the standards that companies working in the medtech area need to comply with.

The following is based on information provided by Dr Oliver Eidel in a blog post about the topic (see below for a link). Consider this post to be an abstract and go to Dr Eidels blog for more information.

When it comes to buying and managing software and IT, here is what you need to know in a quick runthrough (as many prospects and customers have been asking us):
  • It is defined here: Section 4.1.6 of ISO 13485:2016
  • You are asked to do a very commonsensical thing:
    Validate the software that you are using related to Quality Management activities, making sure that activities are proportionate to risks taken.
In a nutshell, the validation process looks like this:
You need three documents:
  • A list of computer software in which you keep track of all software you’re using at your company. [...]
  • A template for a validation plan which you’ll need to fill out for every software on that list. [...]
  • A template for a validation report which you’ll also fill out for every software on that list, unless you determine that you don’t need to test it. [...]

List of computer software: That's easy.

Validation Plan: This is a list with dates where you performed software validations

Validation Report: Kind of a report stating what you exactly did to validate the software you're using. Dr Eidel suggests the following criteria are described:

  • Software Identification
  • Intended Use
  • QM Relevance
  • Risk Analysis
  • Requirements
  • Validation Procedure (Test approach/ procedure)

Once you are doing this for every software used, you are safe.

Thanks to Dr Oliver Eidel who laid it all out in a beautiful an simple way here:

https://openregulatory.com/authors/dr-oliver-eidel/

PS: Of course, relatico can be used in a MedTech or ISO 13485 environment.
Please contact us to find out more.