Guest
Guest
Create New Topic As guest or Sign in
Assign topic to the user
-
Customer feedback
For class III medical devices, looking for guidance to understand what are the responsibilities of a distributor having a full process, from storage and delivery to clinical use activities such as user training and proctoring. this will help me to write a proper quality agreement.
-
QMS training
Hi, I'm having some doubts on ISO 13485, is it necessary to have QMS training once in 6 months, as per the standard?
-
ISO 13485:2016 vs 13485:2012
How to identify the new requirements of ISO 13485:2016 vs 13485:2012
-
ISO 13485 and Staff morale
How can ISO 13485 support and improve Staff morale?
-
Product complaints
Is there a deadline for handling product complaints?
-
Mould validation
How important is the mould validation documents?
-
Conformance with ISO 13485
Does 21 CFR 820 requires conformance with ISO 13485?
-
First qualified person
Qualification procedures need to be developed and implemented for a test or a certain manufacturing procedure. A test, OJT or validation should be included. However, who can be the "first" qualified person? For the validation of the qualification, there needs to be a person to compare. We are in the process of first developing the qualification procedure. Do we need to establish a procedure that specifies the first person to be qualified? Or can anyone or someone who had been doing the job become a first qualified person?
-
Complaint handling and vigilance reporting
Pl. enlighten me on the following: How and where to include the determination of vigilance reporting in the customer complaint procedure or process -
Transition to ISO 13485:2016
We have an assessment of our QMS to 13485-2003 and need to be in line with 13485-2016 what is the best way to accomplish this?