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Can small start up be ISO 13485 certified?

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Guest user Created:   Dec 07, 2022 Last commented:   Dec 07, 2022

Can small start up be ISO 13485 certified?

Is it possible for a small start up where only associates are working (in other words no employees) to be ISO 13485 certified? In addition I would like to ask you if your package ISO 13485 and MDR templates is suitable to comply also for FDA requirements for medical device

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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 Dec 07, 2022

According to the EU regulation, each manufacturer of medical devices needs to have implemented ISO 13485, no matter the size of the company. I know that sometimes is hard to implement a quality management system for only 3 people, but it is doable and mandatory for the EU market. 

In February this year, the FDA published the Quality System (QS) Regulation / Medical device good Manufacturing practice which has to align the requirements from the FDA to the requirements of ISO 13485:2016. For this reason, yes, our Documentation toolkit for ISO 13485 is in compliance with FDA. Considering the MDR technical documentation part of the toolkit, there are differences between FDA and EU MDR 2017/745 differences

Differences are described in the following article: https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

For more information, see:

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