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We are currently using the templates to design our ISO 13485 processes, primarily to apply for CE under the MDR of our new medical device.
In the light of this, you could help me out with the following.
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.
Hi, I'm having some doubts on ISO 13485, is it necessary to have QMS training once in 6 months, as per the standard?
How to identify the new requirements of ISO 13485:2016 vs 13485:2012
How can ISO 13485 support and improve Staff morale?
Is there a deadline for handling product complaints?
How important is the mould validation documents?
Does 21 CFR 820 requires conformance with ISO 13485?
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?
Pl. enlighten me on the following:
How and where to include the determination of vigilance reporting in the customer complaint procedure or process