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Jose Dorbecker
Annual product review / Retention samples for medical ...
1 9

Dear Members, I really appreaciate your comments on the following question: are the requirements from the Pharma ...

Jose Dorbecker Mar '23
David Manalan David Manalan Mar '23
There is no requirement for annual product review per se, and no retention sample requirement unless it's part of ...
Monica Deo
CAPA generation criteria for Medical Device
1 13

Hello,

We have recently started to take an in-depth look at our CAPA system. Our QMS currently states, “a CAPA may be ...

Monica Deo Sep '22
George Marcel George Marcel Oct '22

@Monica Deo
Hello Monica, I would also include risk.

If things are one off or infrequent and easily corrected, with ...

Alireza Khosh
Medical Device Sampling Plan justification
4 32

Hi Everyone,

What are the requirements for Medical Device Sampling Plan justification?

I am looking for a ...

Alireza Khosh Jun '22
Edwin Bills Edwin Bills Jun '22

Sampling plans must be statistically valid. The best way to do this is thru standards such as those available thru ...

David Manalan David Manalan Jun '22

I attach two articles addressing this topic. Even though it's old, Torbeck's article should be read before ...

Ajoy Basu Ajoy Basu Jun '22

Hi Alireza,

While there is no definitive guidance on sampling plans from the FDA, have used the following for ...

Edwin Bills Edwin Bills Jun '22
For Medical Devices FMEA Risk is not the same as ISO 14971 Risk. You should use Risk Analysis Risk and not FMEA Risk. ...
Shamantha Gunawardena
Vendor Qualification of Distributors
7

What are the sample survey questions you'd ask if your supplier is a distributor as opposed to manufacturers? Any ...

Shamantha Gunawardena Mar '22
Timothy McShane
Looking for help on ISO standards
14

Hello All,

I am pursuing a Quality and Regulatory Specialist position in a medical device company and I need to ...

Timothy McShane Nov '21