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ISO 13485 certification

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Guest user Created:   Oct 11, 2019 Last commented:   Oct 13, 2019

ISO 13485 certification

My question is for a company working on user-friendly comprehensive software that can help hospitals or doctors to record all medical data. If they plan to go for ISO 13485 implementation, is it must for all employees to be trained on ISO 13485 and the hired QA person for this role is requires any special qualification other than ISO 13485.

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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.

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Kristina Zvonar Brkić Oct 13, 2019

It is not necessary for all employees to be educated for ISO 13485. There is no such requirement. However, there is a requirement 6.2 Human resources that all personnel performing work affecting product quality must have competencies or must be trained to achieve those competencies. For example, the person who does the programming alone must know the basics of ISO 13485 that are applicable. While, for example, a marketing person does not need to know the requirements of ISO 13485. QA person does need to be educated in ISO 13485:2016. 

Besides ISO 13485:2016, QA person must have knowledge of any other standard that is specifically for certain medical devices. For example, there is a medical software standard IEC 62304:2006 Medical device software — Software life cycle processes https://www.iso.org/standard/38421.html, so QA person must know which requirement from that standard is applicable or not. Also, any medical device that want to be CE marked must be in compliance with the Medical device regulation https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20170505, regardless of the medical device classification.  

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Oct 11, 2019

Oct 13, 2019