Can small start up be ISO 13485 certified?

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:

• FDA vs. EU MDR Technical Documentation Matrix https://info.advisera.com/13485academy/free-download/fda-vs-eu-mdr-technical-documentation-matrix