Competent Authority investigations of FSCAs (Field Safety Corrective Action)

K

KMedical

Hi all

I am looking for your feedback and experience here. Our company is preparing for a compentent authority audit. We have FSCA files under our remit.

I am interested in any information that might be supportive to our preparation for this audit

In your experience, what have Competent authorities asked for, (in relation to FSCA files)
What are their expectations (other that whats stated on MED DEV guidelines)?

What have been weaknesses or hot topics, that we should particularily prepare for?

I thank you, most sincerely, for your responses.
 
K

KMedical

Hi

Thank you both for reviewing this.
Thanks Steve for the link to FSNs.

We have a number of field actions (FSNs) files that are under the scope of the competent authority audit. I am wondering, what way they will audit these field action files. What they are looking for? How they will challenge if the action has been completed etc.

Thanks for any advice
 
You must log in or register to reply here.
Top Bottom