Medical Device Technical File SOP example available?

M

Markey

#1
Hi,

I am currently involved with a pre-audit of our Quality System. One of the feedback items from the Notified Body audit is the requirement for a procedure on the maintenance of the Technical File (eg. keeping devices "state of the art"). Does anyone have a template for this SOP?.

As someone relatively new to Quality I wanted to say what an excellent resource the Cove is. I look forward to contributing to the forum.
 
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S

SteveK

#2
Re: Technical File SOP available?

First off your NB where it quoted that you SHALL ('show me the SHALL' being a famous quote on the Cove) have an SOP for maintenance of a TF. I don't have one - never been asked for one. The 'state of the art' bit is from the MDD - which I believe impacts on the whole QMS not just the TF.:2cents:

If you 'must have' a TF procedure look at the link below if not already familiar with GHTFs concept of a STED, not a procedure as such but a guideline.

http // www. ghtf.org/documents/sg1/sg1final-n11.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

Steve
 
Last edited by a moderator:
S

SteveK

#3
Re: Technical File SOP available?

Should have said "First off, ask your NB where it says you SHALL.........."

Sorry, too early in the morning - brain's grammar check not working (probably still isn't).

Steve
 
N

Nesrine

#5
i m writing a Technical file, what are the SOPs related to this doc?
regarding the CER clinical evaluation report, who must write this doc? can I write it by following a template? I m not CER certified
thanks
 
S

SteveK

#6
First off read MEDDEV 2.7/1 rev 4:

Guidance - European Commission

Ever reviewed or written scientific papers on medical devices, or scientific subjects in general, conducted research, designed actual products, issued patents etc?. If not a NB auditor may take a dim view on your abilities. to write a CER. Mind you I question their technical abilities!

Steve
 

Wolf.K

Quite Involved in Discussions
#7
Ever reviewed or written scientific papers on medical devices, or scientific subjects in general, conducted research, designed actual products, issued patents etc?. If not a NB auditor may take a dim view on your abilities. to write a CER. Mind you I question their technical abilities!

Steve
That's why we only hire biologists with Ph.D. degree and train them to become "Medizinprodukteberater"...
 
E

EthanLoh

#9
Hi,

Procedure for maintenance of Technical File is a rather new requirement during stage 1 audit, especially for new company going for CE mark.

It is not difficult to establish and highly beneficial for the company to comply. Anyway, each Notified Bodies have their own internal requirements. Depend on who you get. :bigwave:

CER is a big challenge to small company when they do not have a clinician or qualified person. It is better to pay some doctor or PHD guys to do the CER.

I once had a auditee's CE mark (Class IIb, implant) revoked by a notified body for failure to provide a CER by a clinician.
 
#10
MedDev 2.7/1 Rev 4 Clause 6.4

The evaluators should have at least the following training and experience in the relevant field:

- a degree from higher education in the respective field and 5 years of documented professional experience; or

- 10 years of documented professional experience if a degree is not a prerequisite for a given task
No PhD required!
 
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