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Main challenge stat up companies face to comply with ISO 13485

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Guest user Created:   Sep 14, 2020 Last commented:   Sep 15, 2020

Main challenge stat up companies face to comply with ISO 13485

What is the main challenge stat up companies face to comply with ISO13485?

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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 Sep 15, 2020

First, you need to educate yourself about ISO 13485, what kind of standard it is, what are the specific requirements in it. If any requirements in Clauses 6, 7, and 8 are not applicable due to the nature of the medical device, those requirements can be excluded.

For example, if your medical device is not sterile, then requirements 7.5.5 Particular requirements for sterile medical devices and 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems are not applicable for you.

If your medical device is software, then several more requirements are not applicable: 6.4.2 Contamination control; 7.5.2 Cleanliness of product, 7.5.9.2 Particular requirements for implantable medical devices. 

Then you need to be sure that you have a medical device. ISO 13485:2016 is applicable for manufacturing medical devices. Definition what is a medical device you can find on the following link:

The next important step is to define your processes and to make all necessary documentation procedures and records. In that, very helpful can be a documentation toolkit. It is a set of pre-written templates, easy-to-use, fully compliant policies, procedures, and records. 

You can find our ISO 13485:2016 documentation toolkit on the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

For more details, please see the following articles:

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Sep 14, 2020

Sep 15, 2020