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ISO 13485 implementation

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Guest user Created:   May 17, 2021 Last commented:   May 17, 2021

ISO 13485 implementation

Thank you very much for letting me put my question. My main concern right now is, is it possible to prepare all the required documents without letting expansive consultant to do it for us? What would be the challenging part while preparing document by company staff? If we use Advisera Templates and experts advice for preparing our documents, how much time will it take to get thing done for class IIa 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.

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Kristina Zvonar Brkić May 17, 2021

With the usage of the Advisera toolkit, you can definitely save a lot of money. Templates are arranged so that they meet all the requirements of ISO 13485 in a logical sequence. Your task is to write down in the documentation the name of a particular job in your company is and possibly to add some specifics. 

On average, we can say that for the company with 10 employees it will take 3-4 months, for the company with up to 50 employees, some 8-12 months.

As for the preparation of technical documentation for a Class IIa medical device, it all depends on whether your product is completely finished (or is still in the development phase), and whether you have done all the necessary tests.

I would like to point out here that if you take the documentation toolkit from Advisera, you are not just getting templates. YOu are also receiving e-mail support, review of the documents, and live on-on-on online consultations.;

For more information please see the following:

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May 17, 2021

May 17, 2021

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