Hi,
I started a small company, making a medical device, and would like to get one of my product CE marked and CMDCAS approved.
I spoke with a couple of consultants and they suggested that ISO 13485 is the first thing I needed to do.
The fee to develop the quality manual was beyond my means especially when I add to it cost of audit etc.
My partner dropped out of the project so I am contemplating three things; either
- find a consultant who would help me with lesser fees
- involve a expert consultant as a partner in the company, or
- use an already made quality manual as a reference, then later run by someone else for review.
Could you help me with any of these? or suggest other ideas.
Sincerely,
Zak
Thank you gentlemen for your prompt response.
Apparently time is not a factor.
Please make few recommendations. What would be helpful to me is some sort of document (book or CD) I could use as a reference. How a particular item needs to be addressed etc. ..Zak
Thank you for the information, reading this post, I was and to a degree still am in the same position. I am preparing my documents for the audit for Canada in August, any help is welcome as I am struggling. I run my company alone, and have developed a medical device, which I became the manufacturer. I know that we all have to be in line with the meddevs which replace 93/42/EEC by next March, is there anything in the new meds which I need to be looking at now for the audit?
Is it mandatory now that we have to have an expiry date on the box of a medical device? My device will last forever and to date has not needed an expiry date.
Thanks for any help you can offer.
Yes. We do indeed have lots of information here in the Cove to help you achieve your goals.
It may seem crass, but I'm a pragmatic businessman/consultant, so the first thing I would ask
(in the free interview (in-person or over-the-phone) ALL consultants should give before making a fee proposal) is
"Just how much capital do you have to spend for a consultant to hold your hand through the registration process of obtaining FDA and ISO 13485 registrations, including CE marks where necessary?"
The net price may be lower than you currently anticipate or it could be much, much more! If you don't have ready cash, some consulting firms are willing and able financially to work out terms for payment over time, or, as zkoulou suggests, take an ownership stake in the company. In any case, the consultant will tell you what you need to know if you are honest and forthright with him. Think of it like a doctor-patient relationship: the doctor can't help you if you aren't truthful about your symptoms. Note this is different from the payment which must be made to a certifying body (registrar) for the certification process for ISO 13485. I'm not aware of any of them who will work out a payment over time for their certification service. By the rules, such registrars MUST have an arms length relationship with the client.
Most reputable consultants are flexible enough to to give clients tips on doing a lot of the "busy work" themselves, with oversight and review from the consultant to assure it will pass muster in the review process.
When and if you decide to go the consultant route, you should be sure to differentiate between a consultant who will give you advice and help with strategy on achieving certifications in the most efficient and economical way possible and those consultants who merely have a boilerplate, turnkey type agenda suitable for both small and huge operations at a relatively fixed price.
One caveat: Examine any proposal closely which seems to promise success in achieving registration within a forty or sixty day window even before the consultants have an in-depth interview with you..
