ISO 13485 & EU MDR - Expert Advice Community

Additional requirement to ISO13485 that has to be addressed for MDSAP

My question is about MDSAP. I like to know what additional requirement to ISO13485 hqs to be addressed for MDSAP.

Fulfilling documentation requirements of ISO 13485 and MDR in Quality Management System and demonstrating it in matrix

How to fulfil documentation requirements of ISO 13485 and MDR in one Quality Management System and how to demonstrate this in a matrix

Would ISO 13485 be compliant with 21 CFR part 820?

My company sells blue light blocking glasses in the EU. I now want to sell them in the US. I understand they are a Class 1 medical device hence need FDA registration.

As part of FDA compliance I understand I must have and follow a QMS. I understand my QMS is regulated by 21 CFR part 820 and if I understand correctly an ISO 13485:2016 QMS would be compliant with this. Is that correct?

I am therefore interested in your ISO 13485:2016 template which I can use to create my 21 CFR part 820 compliant QMS.

Software Requirements

Firstly, how would the pack apply to Software as a Medical Device (SaMD)? Looking at the preview there is a lot that seems unnecessary as it is focused on the development of a physical product?

Secondly, on the software front where would Software Requirements be specified (e.g SRS Doc) is this kept as an external doc and referenced? On a similar line, what about Software Testing (e.g. unit testing, user testing)? Would you again keep an external record and link to it in the “Record of Software Validation”?

Section about intended use

IN the toolkit we have purchased, I cant seam to find a section about intended use. Which document caters for that? What ive found so far is just technical file, but not to the extent I thought was required.

Design and development process

I want to ask about clause 7.3 of ISO 13485:2016. If we produce a medical device that is equivalent to another device in the market but make some changes to it, is clause 7.3 applicable for us?

Resolution timeline for closing NC's and MDR/UDI and EUDAMED

1. Hello, Could you advise on defining the resolution timeline for closing Critical, Major and Minor NC ? The product is '' image viewer software ''?

2. Could you advise if the company preparing for MDR transition from MDD needs to register for UDI/ EUDAMED if they will not be placing the product on the EU market?

ISO 13485:2016 , regulatory requirements

I would be interested in the process of meeting the regulatory requirements according to ISO 13485:2016. What are the mandatory documents ? How to handle the review process for all standards/ legislation and other regulatory documents in the company ?

Requirements for SAMD

I am looking for some help on Health Canada requirements for SAMD ( software as Medical Device) for a Dental radiology software. I feel it is classified as class II.

Please let me know if you have any knowledge on this- which clauses of ISO 13485 can be excluded>

Multiple titles

Under ISO 13485, would the FDA have a problem if the CEO of a company would also have a business card that shows him or her as a business development representative? Two business cards with two separate titles?