ISO 13485 & EU MDR - Expert Advice Community

Why ISO 13485 didn't implement changes and format of ISO 9001:2015 edition?

Why did ISO 13485 not remain in line with the ISO 9001 standard and did not implement the changes and the format of the 9001:2015 edition?

Implementation questions

1. How does one determine an organization has enough employees to do the work?
What sort of things need to be looked at, to ensure a company is adequately staffed?

2. What sort of things can we do to determine training effectiveness?  At the initial training we can have an on the job training or when someone observes you and signs you off on a particular task, but after
What are some industry standard practices.

3. Also if my company has an Asset Management, Gowning SOP, Environmental Monitoring and Pest Control procedure that cover the different points in your toolkit example for the infrastructure and work environment procedure will that be good enough or does the information need to live in one document titled “Infrastructure and Work Environment?”

Does Medicine Product Class 1 need Certificate from Notified bodies according to ISO 13485?

I attended the Webinar “Overview of steps needed to comply with EU MDR”

Who needs to get certified: included Manufacturer of Class 1 medical devices. What do you mean by certifying? Does it mean to get certified by ISO 13485:2016?

To be honest I have studied the complete EU MDR. By attending your Seminars and Q/A sessions. I understand the Medicine Product Class 1 does not need the Certificate from Notified bodies according to ISO 13485.

We just need to prepare our QMS according to ISO 13485 and EU MDR.

If I am understanding it wrong please guide me accordingly.

Would medical face mask necessarily need UV radiation sterilization?

Just curious would a medical face mask necessarily need UV radiation sterilization? Currently I am planning to certify under ISO 13485 in order to supply medical face mask to hospital and healthcare center. Thank you!

ISO 13485 requirements for virtual IVD manufacturer

Hi there, I will like some advice on the ISO13485 requirements for a virtual IVD manufacturer which only designs the device?

Issues from MDD to MDR in terms of mainly clinical evaluation and investigation

Issues from MDD to MDR in terms of mainly clinical evaluation and investigation, classification, etc.

How to effectively use CAPA to improve Quality Management Systems?

 I need to learn to how to effectively use CAPA to improve Quality Management Systems under ISO 13485

MDR Technical Documentation

1. Is it acceptable under MDR to have Technical Documentation for medical device families rather than for every individual medical device?

2. Is it acceptable under MDR to group medical device families based on the basic design and performance characteristics related to safety, intended use and function as defined in ISO 13485:2016?

Management representative in ISO 13485

Hi! We are wondering about the management representative in ISO 13485. We do not have this competence in house, is it possible to outsource that resposibility, or does it have to be a person in the management team?

Can CE agency also recognize the same 13485 standard?

I assume that CE agency also recognizes the same 13485 standard?