Ansi/aami/iso13485:2003 + Iso14971:2000 + Iec60601-1-4:2000 + Mdd93/42/eec

[Numan]

Dear All,
We are manufacturing medical devices, and I am the R&D Manager of the company. This year was the 7th audit I had in this company, and at each audit I never miss to get a minor nonconfirmity regarding the procedures for design and development. I think that is enough, and that is the reason I attended to this community.
I need help&suggestions from all to update and/or change my current procedures, i.e. design and development procedures at ISO13485. In the meantime, the procedures should cover requiremenst stated at MDD, IEC60601-1-4, and IEC14971.
Can anyone help me? Are there any sample procedures ready with examples of application?

Many thanks in advance
With Best Regards

 

[Al Rosen]

Dear All,
We are manufacturing medical devices, and I am the R&D Manager of the company. This year was the 7th audit I had in this company, and at each audit I never miss to get a minor nonconfirmity regarding the procedures for design and development. I think that is enough, and that is the reason I attended to this community.
I need help&suggestions from all to update and/or change my current procedures, i.e. design and development procedures at ISO13485. In the meantime, the procedures should cover requiremenst stated at MDD, IEC60601-1-4, and IEC14971.
Can anyone help me? Are there any sample procedures ready with examples of application?

Many thanks in advance
With Best Regards

May I suggest you post the details of the nonconformities and your present procedures for D&D and Risk Management. This will allow us to review them and make suggestions.

 

[qagirl]

I found a good source of procedures

My previous boss purchases a procedure packet from a company called AQApress.com
I assure you that I don't work for the company, but they sell a whole packet of canned procedures that are pretty good and cover all of the basics of ISO 13485:2003 and others. It's not cheap - but it's cheaper than hiring a consultant. Hope this helps.

 

[RCW]

My personal experience with the AQA documentation wasn't the best. This goes a few years back when I purchased the ISO9000:1994 book with documentation. I originally set up my quality system using this. After a pre-audit the system was found to have holes in it (and I even agreed with the aduitor, imagine that!). Granted this was a while ago and their documentation could have improved since then, but that's my story and I'm sticking to it.

 

[Megani]

Megan

No matter what package you might consider buying, you still have to go the extra mile and QC or audit your processes. AQA has not been consulted to evaluate your processes. They can provide you with a guide, not the actual work that you do. As a global GXP QA consultant, what I can suggest to you is to take pad and pencil and go through each department process and flow chart the following: what is done in each department, how it is done, how it is documented, how your people are trained, how you make sure the process is the same (especially if you have more than one shift), how you implement a change, how that change is relayed to your personnel, how that is documented, trained, and placed where it can be easily reviewed, and finally how the old process is retired. Then once you have flow charted that out making sure you ask "What if it doesn't?", match up the other departments and see if it all fits. If you can track your full process, matching your documentation, communication, and training, the FDA or any other regulatory agency you may deal with, should not have a problem with your company providing that you made sure you met regulatory compliance when developing your processes. That is a consultancy in a nutshell. I hope it helps! Good luck!