ISO 13485 implementation

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:

• Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
• Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
• How can ISO 13485 help with MDR compliance? https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/
• What are the EU MDR technical documentation structure and requirements? https://advisera.com/13485academy/blog/2021/04/06/what-are-the-eu-mdr-technical-documentation-structure-and-requirements/