ISO 13485 & EU MDR - Expert Advice Community

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?

Applicable exclusion from standard

We manufacture IVD Rapid Test Kits (Malaria pf, Pregnancy etc.). As you can see on the attached, our medical device manufacturing processes involved Purchasing (Raw Materials), Cutting, Assembling, Sealing, Packaging & Labeling and Marketing & Sales. We do not service our devices and there is no software validation. What exclusion from the standard is applicable in our situation? Hope to hear from you soon

Quality manual & Procedure under the ISO 13485:2016

I am newly join to a medical device supply company which under the restructuring the management and nature of its businesses. The company has certified to the ISO13485:2016. However, under the new structure of business strategy, few activities of the company (as such production of medical device) is taken off from main process line as few others as well.

My question is, do the company need to revise the entire documentation of Quality manual/procedure before the upcoming survelience audit?

Will it impact the certification to the ISO 13485:2016

Please help to highlight your opinion on my curretn situation to corelated it with the certification of ISO 13485:2016

Admin verification checks and physical verification checks

Is there any forms available for admin verification checks and physical verification checks?

Budgeting the EU MDR implementation

To start with one large hospital, MDR Dept only, 28 staff in processing, what should we budget?

Who needs ISO?

In Canada, we hold the licence for a viral transport medium.  We are going to hire a 3rd party contractor to actually manufacture the medical device.  Who needs ISO?  Us? The 3rd party contractor? Or both?