Seeking: cGMP FDA-based Quality Manual with ISO 9001 and EN Requirements

[LGDeneault]

I was just recently hired by a small medical manufacturing company and I have been given the responsibility of helping it cGMP compliant with the FDA. The company also desires to be ISO and EN compliant as well (surprise, surprise!).

Anyway, I have pieced together a Quality Manual but, before I go off and spend weeks writing SOPs (Records Management, Management Review, Training, etc.) I was wondering if any of you had a template or boiler-plate that could be used to meet the requirements outlined in the FDA-based Quality Manual *AND* position us for ISO and EN certification. I can fill in the details but, it really would be nice to have an infrastructure to follow! Thanks, in advance, for your time and consideration!

Best Regards,

LEE

[Wes Bucey]

Tell us more about your company and its products, Lee, without violating any privacy concerns.
There is a lot of variation in "medical" and some things like "risk assessment" and SOP are not readily transferrable from company to company.
Are you at least starting with a full set of FDA and EN regulations applicable to your company's products?

One thing I am hearing more and more from every source I have in FDA-regulated industries is that the FDA is becoming much more efficient and aggressive in its inspection activities with companies under its purview.
Here's a kind of caveat warning newbies should keep in mind when dealing with the FDA: http://www.advamed.org/business-solu...le-ciampa.html

It is absolutely important to note that the FDA expects the deed to match the word contained in the manual and other documents. If not, the FDA has a very compressed timetable for dealing with non-conformities. "Jawboning" by a target of a FDA action is suicidal. FDA expects documented action, not excuses. A higher percentage of cases are being shifted to criminal prosecution. Fines are humongous! (I've been told privately that legal fees and consultant fees really mount up fast when defending an FDA action.)

[LGDeneault]

Greetings All!

I am in search (to purchase!) of a standard for "patient lead wires" and "electrodes" for both TENS and IFC stimulators. AAMI doesn't have any so I thought that I might ask all of the nice folks at "Cove"...

Thanks, in advance, for your time and consideration...

Best Regards,

LEE

[Al Rosen]

Originally Posted by LGDeneault

Greetings All!

I am in search (to purchase!) of a standard for "patient lead wires" and "electrodes" for both TENS and IFC stimulators. AAMI doesn't have any so I thought that I might ask all of the nice folks at "Cove"...

Thanks, in advance, for your time and consideration...

Best Regards,

LEE

Lee:

I don't know what an IFC stimulator is, but have you looked at:

IEC 60601-2-10(1987-12), Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators?

Also check the FDA Database for standards. http://www.accessdata.fda.gov/script...rds/search.cfm

BTW,
I think this is in the wrong place and needs a new thread in the medical devices forum. http://elsmar.com/Forums/forumdisplay.php?f=44

You might get more help there.

[Al Rosen]

Lee:

Here is another document I found on the FDA web site that might be useful http://www.fda.gov/cdrh/ode/124.html#ref5