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Class IIa product

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Guest user Created:   Jul 27, 2020 Last commented:   Jul 29, 2020

Class IIa product

We are looking to expand our activity in *** as a gate to *** countries and the EU.
Our solution is a support information system for physicians helping them in better identification and treatment of respiratory infectious diseases.
We would like to know what it takes for ISO approval as part of the CE submission in time and money?

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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 Jul 29, 2020

Following steps are necessary for the getting ISO certification:

    1. First, you need to implement the ISO 13485:2016 in your management system and everyday work.

    2. Then you need to ask for the certification according to the ISO 13485:2016 from the certification body.

It is rather hard to estimate how much time you will need for the implementation process because it depends on many things like: number of the employees, do you have any experience before with quality management systems, how complicated your processes are, and so on. On average, we can say that for the company with 10 employees it will take up to 3 months, for the company with up to 50 employees, 3-6 months. But, once again, this is just the estimation.

Considering how much money you will spend, again depends on your previous knowledge about quality management systems and the availability of your employees to dedicate to the implementation of a quality system. You can do it by yourself, which if you do not have previous experience, can be the longest way. You can hire a consultant or you can buy a documentation toolkit - pre-prepared template with all the necessary requirements from the standard and you just have to adapt them to your processes and needs.

Following articles can help you more to understand this process:

On the following link, you can see how our ISO 13485:2016 Documentation toolkit looks like: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

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Jul 27, 2020

Jul 29, 2020