ISO 13485 & EU MDR - Expert Advice Community

Signing electronic documents

We are preparing for an inspection, which will be next week on Thursday. (FDA Mock). Which point of the regulation states that electronic documents do not need to be signed? Is it allowed to use the Google Suit system at a medical device manufacturer? (Data stored in the cloud. If not which rule can I refer to.

Implementing ISO 9001 alongside ISO 13485

We are designing a system to transport medicine by drone. We understand we need to have ISO 13485 certification. Do we also need to have an ISO 9001 certification or is 13485 a superset of 9001? Thanks.

How to use the ISO 13485:2016 Internal Audit Toolkit

I am looking for templates to use for conducting internal ISO 13485:2016 audits, such as Audit plan or Working documents (checklists, agenda, report). These templates appear to be designed for an audit of an entire company, how could I use them to audit one department at a time?

Medical devices vs. AI and software driven medical devices

if I have to establish and develop ISO 13485 for a company predominantly is AI and software driven medical devices, what are the main differences between medical device vs the above mentioned medical device.

Stage 1 audit

What can a company expect from Stage 1 - 13485:2016 Auditor?

Certification qualification

If a company does not existingly have a medical product in its production, does it qualify for certification?

Calibration

 have a question in relation to our external calibration .
I have started a new job and a new role in calibration .
my question is for years the company has had some of the equipment calibrated from an external company and as i was going through some of the calibration certs and i noticed that their reference equipment had a tolerance of +- 1.5 % rH and our equipment has a tolerance 3% rH. is this expectable for ISO13485 (this means a ration 2:1)

udi for Legacy devices

We have 1 product group under CE MDD.(Legacy medical device)

This certificate is valid till end 2023.

Must we  place new symbols/UDI codes acc. MDR  on our labels after 26-05-21?

There are no expected changes to the product.

Appendix for Design and Development

why, for example, the appendix for Design and Development are not all in one?

Guideline on oxygen tank calibration

Need your help to tell me is there a guideline on the oxygen tank?calibration?