I have a client, that will be getting into class 2 medical device design and manufacturing. I need to brush up on the requirements for submitting technical reports...where do I head for that information?

barb,

Do you need info on 510k submissions? Or, reports from field tests? How about 803 or 804 submissions?

You can try:

http://www.fda.gov

to start or check out the FDA QSR section of my page below.

Regards,
Don

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Just the ramblings of an Old Wizard Warrior.

They are all set on 510k......something about a SIMCO report, or other similiar acronym. they are concerned about the work involved to do a report..I have no clue, and want to go in with a bit of homework done next week...I have been into the electronics of thier stuff....now I need to get imvolved with the end item, and associated regulations. Ordinarily I would find an expert to pass it to...but I decieded I wanted to learn it

Without knowing more details, I can only suggest you try this:
http://www.fda.gov (http://www.fda.gov/search.html) - Link was: /search.html

Regards,
Don

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Just the ramblings of an Old Wizard Warrior.

went wandering around the FDA sites yesterday and found some real good and useful stuff...but not what I needed.

a bit of history:

Its a fairly new company, they have expanded their resources in a merger...which is how I came to know them. All of 4 people and me right now. They are in pre-production. They used to make a simple diagnostic instrument for opthmology purposes..they have enhanced and modernized (computerized) the product, and merged with a software guy and changed their name. It is level 2 'cause it shines lights into the eyes for diagnostic (glacoma) purposes....very limited invasive device...little to no risk, as the diagnosis does not result in critical/serious activities. They checked out the 510k and did not have to do another, but are concerned about a technical report for (what sounded like SIMCO) I may have to do for them, as well as coordinate the ISO 9001 and CE mark stuff. The CE mark testing is complete. Their ISO audit was a mess (same agency as the CE mark). From what I see in the report and their documentation, and the one room facility...they got taken over the coals by a in-secure auditor. (they have produced 2 prototypes to date. I am ok with some of it, and am sure i will fare pretty well once I understand the report I will have to do....they are looking for a commitment in time and cost so they can plan accordingly.....I get to be their "quality manager" adhoc.. if you will...I am interested in the medical device sector experience. But I don't want to short change them. They know I have little experience in this portion of the industry...(my medical device exp. comes from supplying critical components to a manufacturer of med devices, and helping him meet his requirements.) BUT I want to talk intelligently at least...when I go in next week.

I apologize for not responding to your last post sooner. I had document review Monday and Tuesday and was a 'little' busy.

Anyway, I have searched through all my references and cannot seem to find what you are looking for.

…once I understand the report I will have to do…

After this, I am sure the FDA site can help, but if not let me know. I will look through my stuff again.

BUT I want to talk intelligently at least…

I am sure that will not be a problem.

Regards,
Don

Barb,

You need to check the indications for use for this device. For different applications, such as details of your specific procedures, this can be Class 2 or Class 3 device. In addition, what type of "limitations" this device posibly create? What is the design changes from prior device?

FDA will consider device that monitor eye movement as Class 2, but ophthalmic suture is Class 3. Do you have enough information?

In reference to SIMCO? word, I know some devices required "registration" prio to ANY use. This can be this type of device.

Hope this will help,
Mike

Everything helps at this point Mike, LOL.

The device is a read only optical device. no suture. It bounces light off the eye to diagnois glaucoma, and measure deterioration. The changes are mostly upgrades and modernization..software enhancement, dos to windows, wand data entry, nicer case, more efficient electronics. They already cleared the 510k report ..they didn't need one. did I tell you it has the CE mark already? After getting familiar with the documents they gave me, I feel much better equipped to handle the project....now on to the heavy stuff....gotta land the job.

Barb-

If they have electronics upgrade, you want to check if someone really got a new 510(k) or one person in the office said "it's OK"??

Good luck, Mike

apparently the testreport acronym is SIMCOM and it is CE mark related..... does that help you understand my question better?

Yes, it help me to understand this better. Simcom Inc. or Corp. offers a set of books to help companies with compliance with 3 basic European Standards. The books are presented in a checklist format and contain data for recording results as required by standards. These documents design to take the engineer thru the standards and they are long,-60 to 80 pages. Manufacturers who design and test their own equipment need this as part of the Declaration of Conformance that you need for CE.

Big JOB!!!!!!!!!

Good luck, Mike

This is my first post.

From what I have read in this thread, it seems that you may want to refer to and follow the Medical Device Directive or MDD(COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices). If you are interested, I found a copy on-line at http://europa.eu.int - Link was: /eur-lex/en/lif/dat/1993/en_393L0042.html

It sounds as though you need to compile a technical file as described in the MDD. The major (not only) requirement is that you meet the essential requirements listed in the above document in Annex I.

Before you compile the technical file is in your best interest to determine your device's class according to the European system (class I, IIa, IIb or III) and then determine the conformity assessment path you want to take.

I hope this is helpful.

Just curious, who is your Notified Body?

Tom

I believe the notified body is ITS, don't have the contract yet, so I am missing details....I am just getting prepared....as I know they are in a hurry.

thank you for the direction...am headed there now.

Barb,

a great source for CE marking and technical file guidance documents is the UK medical devices agency (The MDA is The UK's competant authority for CE marking medical devices, and are amongst other things, responsible for appointing the notified bodies)

http://www.medical-devices.gov.uk - Link Was: /reg-guid.htm

hope this helps,

Andrew.

Are you familiar with 510k submissions? Medical Device company seeks Regulatory Submissions Manager in the Bay Area...
Marguerite Bache