Technical Files Sections ? Have you the experience asks a NB?

Just some recent experience I thought I would share relating to a NB review of a Technical File for continuing CE certification (not actually a humidifier ? this is just an example I used previously in the post referenced). I had the following NC and Observation raised. Note that I had to close-out the Observation as if it were in fact a NC. I am also the sole TF author and only QA person.

Now I?m a bit long in the tooth now and have the experience indicated. So how other SMEs manage; with possibly limited experience and personnel in these areas, with respect to putting together these Technical File sections (and other parts) I do not know.

Non-Conformance

?Please provide the information on the personnel involved in the generation of the Risk management report and their experience with these devices and any training or experience in ISO 14971.?

I added a file note (below) to my Risk Management (RM) section to meet this NC ? this was accepted.

QA Manager (Joe Bloggs, BA Hons, MSc, NEBOSH Cert. ? JB)

JB has been with the company for circa ?n? years, and has developed an in depth knowledge of the company?s products, including the Humidifier unit during this time (overall circa 30 years? experience with medical devices) Experience being gained through interpretation of engineering drawings e.g. of the Humidifier/component parts (trained to BS 308 standards, 10+ years practice in interpreting and approving drawings for medical device tooling in the Pharma industry). Also JB has gained knowledge of the device through preparation of Works Instructions, IFU, detailed Maintenance & Service Operation Instructions, Servicing Schedules, complaints analysis, risk assessment and usability analysis. Experience in ISO 14971 is through self-training and experience of utilising the standard in the preparation and constant review and updating of ?n? Technical Files, including their Risk Management Files. JB has also had formal training in conducting Product and Process FMEAs and Value Engineering/Value Analysis.

I also added the experience of people involved in the design of the product and their input to the RM.

Observation

?Please also provide information on the experience and knowledge of the author of the clinical evaluation.?

In my literature critique section of my Clinical Evaluation (see my previous example http://elsmar.com/Forums/attachment.php?attachmentid=13006&d=1280484501) I have now modified it to add a section b - again this was accepted.

b. Analysis of and references to the literature

An extensive review of available literature has been conducted. All possible web based sources have been used, including specific medical related databases such as Medline, Cochrane Collaboration, Pubmed etc. Adverse incident sources were also utilised, including FDA?s MAUDE and other regulatory sites/databases i.e. MHRA, Afssaps, bfarm, Salute, TGA etc. Apart from incident reports, other actual primary sources could be in the form of text books, published journal papers/abstracts, patents, competitor literature, articles from healthcare publications (e.g. Nursing Times), healthcare, university and related organisations? literature (e.g. WHO) etc. The limitation of data or information referenced being not using anecdotal evidence, hearsay and similar unreliable/unprofessional sources. The ultimate judgement on the suitability or otherwise of the literature is made by a published scientific professional with experience of medical devices (including evaluating associated data and literature) from class I to class III types (from a respiratory spacer to an arterial prosthesis), covering a period of 30+ years. Key words used for the search; used singly or in Boolean logic combination, included but were not exclusively limited to: humidifier, bubble, water, bottle, breathing, diffuser, sinter, respiratory care, medical, flowmeter, oxygen, pop-off valve, ISO 8185, 35113 (GMDN), BTT (MAUDE reference code) and competitor names.

Basically I used the guidance in MEDDEV. 2.7.1 Rev.3 (Methods section) as a catch all.

Hopefully this information may be of help to someone out there.

Steve

Steve
Like many of us working for small(ish) organisations who don't have 15 QE's 50 engineers, doctors consultants etc on the books This is will be a great help when (and I am sure it will) it crops up for us. Please lets us know how the NB took this.

Hi Rob,

Glad to know I am not alone in this situation and that this post is likely to be of help to you. The NB auditor accepted these various statements and then closed-out this particular Technical File.

Steve

Hello,

I am having a similar experience. My doubt is that our NB is asking for the "CV" of the personnel performing the clinical evaluation. As also in one instance, they asked for copies of diploma's and degree certificates performing the evaluation.

MEDDEV 2.7.1 Rev 3 for Clinical Evaluation states in the NB Assessment of clinical data section:
3.3.1 relevance of the author’s background and expertise in relation to the particular device and/or medical procedure involved

Click to expand...

For which as described in the earlier posts in this thread, information about the author's profile could suffice.Is it justified to ask for CV and degree/diploma certificates for proving the competency of the author? I think that might be pushing around a little too much.

I would appreciate if someone can share their ideas on this.

Thanks!

shruti_hiregange said:

Hello,

I am having a similar experience. My doubt is that our NB is asking for the "CV" of the personnel performing the clinical evaluation. As also in one instance, they asked for copies of diploma's and degree certificates performing the evaluation.



For which as described in the earlier posts in this thread, information about the author's profile could suffice.Is it justified to ask for CV and degree/diploma certificates for proving the competency of the author? I think that might be pushing around a little too much.

I would appreciate if someone can share their ideas on this.

Thanks!

Click to expand...

Hi,

If you look in MEDDEV. 2.7.1 Rev.3 - CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES - Appendix F, item 3.4.1, you'll see that

This critical evaluation should: be written by a person suitably qualified in the relevant field, and reviewed and approved by an expert knowledgeable in the ?state of the art? and able to demonstrate objectivity

Click to expand...

I suppose that the CV and the certificates are expected to allow the NB to confirm that these criteria have been met.

Cheers,
Ronen.

Thank you so much for the reply.

I agree with the point quoted in Appendix F, but if the objectivity can be demonstrated with a short description of the author, then I feel it could suffice.

It does not explicitly state that CV or diploma's will be needed to verify the criteria. If the same can be proved by any other means, can it be acceptable?

Another aspect that can be considered that MEDDEV is guidance document and the criteria set in it is not mandatory. In such a case, the interpretation of the item 3.4.1 can be relative to the author to demonstrate his/her competency to write the same.

I may be very well be wrong too..but that's just my opinion.