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Getting ISO 13485 - potential timeline and what is important

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Guest user Created:   Aug 31, 2020 Last commented:   Sep 07, 2020

Getting ISO 13485 - potential timeline and what is important

We got a reject of work related to lack of ISO 13485. I would like to have a feedback regarding what is important here and what potential timeline that might be - to get 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.

Expert
Kristina Zvonar Brkić Sep 01, 2020

Standard ISO 13485:2016 is a standard that covers a quality management system for a manufacturer of medical devices. For a company to be certified against ISO 13485, it needs to be in the medical device industry (manufacturer, distributor, importer). There are specific requirements that are connected with the specialty of medical devices like sterilization, installation and service activities, traceability of the medical device production, special requirements for traceability of implantable medical devices, validation of software is software is a medical device, and so on. 

The process of implementation is to create and document all of the processes required by the ISO 13485 standard, as well as customer and regulatory needs. Our ISO 13485:2016 toolkit combines documentation templates and checklists that demonstrate how to implement this standard through a step-by-step process. In addition, you can access help from our experts to keep you on the right path, ensuring a straight-forward journey to ISO 13485 certification. You can buy the whole toolkit, or you can buy separately documents that you considered that you need.

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 3-4 months, for the company with up to 50 employees, some 8-12 months. But, once again, this is just the estimation.

For more information about ISO 13485:2016 please see the following articles:

You can see how our ISO 13485:2016 Documentation toolkit is composed here:

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Guest user Sep 04, 2020

Hi Kristina,

thank you very much for your reply.

I have one more question or clarification:

  • we are a software development house
  • and we don't own the product
  • we only do provide engineering

Having this in mind, are there some specifics that are mandatory for product owners (for sure they need to have the complete set of prooves of quality) and mandatory for service providers (here it is also important for sure to have a perfect development process, but maybe not so tough)?

Maybe these nuances exist and it is important to know.

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Expert
Kristina Zvonar Brkić Sep 07, 2020

If I understand correctly, your question is for medical device software. For manufactures of medical device software, necessary is that ISO 13485:2016 must be implemented. The next important requirement is a validation of that software that needs to be in compliance with ISO IEC 62304:2006 Medical device software — Software life cycle processes. 

If you do not own the product and are not responsible for placing the software on the market, you only have to have implemented ISO 13485:2016. Product owners also need to have implemented ISO 134895:2016, but also the manufacturer is responsible for preparing the Technical documentation in accordance with Medical device regulation (2017/745). Each medical device must be classified according to the rules stated in MDR Annex 8 – Classification rules - https://advisera.com/13485academy/mdr/classification-rules/.

Medical devices can be classified into the following 6 classes: Class I, Is (sterilized medical devices), Ir (reusable medical devices), IIa, IIb, and class III. Class, I medical devices can be placed on the market without Notify body, while other classes require to Notify body. 

After preparing the Technical file, the manufacturer is responsible for certified medical device software with Notify body for class Is, Ir, IIa, IIb, and class III. 

More information you can find on the following link:

For any other particular question, do not hesitate to contact me.

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Aug 31, 2020

Sep 07, 2020