ISO 13485 & EU MDR - Expert Advice Community

Change request procedure

I noted there is not change request procedure or form template in the package. Is it covered in any other procedure? Also, I could not find Goods In and Goods out procedure. will these be developed. Please advice.

Legal and statutory requirements associated with ISO 13485

Am looking for the legal and statutory requirements associated with ISO 13485

Is clean room installation mandatory?

Hi there, the questions is - Does ISO 13485 depict that there has to be a clean room installed?

Information on risk classification for IVDs under new IVDR regulations

I need more detailed information on risk classification for IVDs under the new IVDR regulations. This is referring to the EU IVDR.

Requirements for custom service business to be compliant for ISO 13485

what are the requirements for custom service business to be compliant for ISO 13485?

Parameters for clean room

I am looking for parameters for clean room

Some Information regarding ISO 13485 and ISO 9001

I am working in a manufacturing company of surgical masks in Dubai I want to know does Manufacturing of Surgical Masks lie under the ISO 13485 scope? and If We implement ISO 9001 in our company, does we require to implement ISO 13485 in the company or is it same..

Is ISO 13485 for medical devices only?

ISO 13485 is for medical devices only or for products as well like hand sanitizers and chemicals used on masks?

ISO 13485 for Class 1 FDA medical device

What are the requirements if any for FDA class 1 medical device to comply with ISO 13485

ISO 13485:2016 clause 4.1.1 - documenting roles