ISO 13485 & EU MDR - Expert Advice Community

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?

List of internal and external documents

If we have all documents saved in an electronic folder, do we have to have the List of Internal Documents?
What are the external documents?

Relation ISO, MDR and CE

For initial research I am wondering how CE marking, Medical Devices Regulation 2017/745, ISO 14971 and ISO 13485 are related to each other?

Rework procedure and Clinical evaluation for media mfg

1. Is there a rework procedure in the tool kit?  I did not see it in there and I believe it is an ISO requirement for clause 8.3.4.  Thank you.
2. I have a question about the clinical evaluation requirement.  What exactly is needed for media manufacturer class 1 medical device?

In looking at the documents in the toolkit it I am not sure if it applies.

3. Also when is a CE mark required?  How do I apply for a UDI # since we don’t currently have one?