Guest user Created: Feb 06, 2019 Last commented: Feb 06, 2019

ISO 13485 for small companies

It's regarding the standards fit into an organization with only 2 employees. We develop software for medical image management and (as it seems) need to get a 13485 compliant QMS in order to re-register our products according to MDR. The standard seems to be more geared towards larger organizations (talking a lot about management, CEO, CMO etc..)

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Verlene Law Feb 06, 2019

Answer:

The Standard is applicable to any companies dealing with medical devices. It does not take into account the size of the organization. For the case of smaller companies, it is very common for the founder and director to assume many roles in the QMS such as Management Representative and process owner. Your company is dealing with Medical Image management, there might be some clauses that can be not applicable to your case making it simpler for you to adopt the ISO.

For more information, please refer to:

Diagram of ISO 13485:2016 Implementation Process
https://info.advisera.com/13485academy/free-download/diagram-of-iso-134852016-implementation-process

List of mandatory documents require d by ISO 13485:2016
https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/

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Feb 06, 2019

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