Developing an ISO 13485 System - New Small Medical Device Company

Z

zkoulou

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
 
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R

Roland Cooke

Re: Developing an ISO 13485 System

The problem is, Zak, that even if you downloaded a Quality Manual - and you probably could - it's only the bare minimum of what you would need to do, in terms of creating procedures, determining and meeting your regulatory responsibilities, and developing evidence of strong quality assurance.

It is possible to do that all yourself, but only if you know what you are doing. Otherwise, my recommendation is to get some help from whatever source makes the most sense.



If time isn't a factor, your best bet would be to do loads of research - buy a book or two (Elsmar can help with recommendations), - and then put it all together yourself.

Hire a reliable consultant to come in and do the internal audit for you. That will show up any major holes in your system, and also provide evidence of independent qualified internal audit, which you will also need.
 

Stijloor

Leader
Super Moderator
Re: Developing an ISO 13485 System

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 dopped out of the project so I am contemplating two 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

Hello Zak, welcome to The Cove Forums! :bigwave: :bigwave:

There a ton of information here about ISO 13485 including ideas about quality manuals and other relevant documents. I would look at that information first and then determine if you really need a consultant. Use the search function and the Post Attachments feature.

Let us know if you need further help.

Stijloor.
 
Z

zkoulou

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
 
Last edited by a moderator:
R

Roland Cooke

The best things to start with are:

Everything on Elsmar: ISO13485 forum, FDA forum, CE forum, ISO9001 forum, others as appropriate.

Get a copy of ISO14969 (guidance on ISO13485). Your local library/university may have a copy you can read, but you will want your own soon enough.

A lot of documents from www.ghtf.org

Download the Canadian regs

Consider joining ASQ, maybe RAPS as well

Find local companies/people that can mentor you e.g. via ASQ, Elsmar, Chamber of Commerce etc. If you can get a tour of a (non-competing, small/medium) medical device company, you may be able to review their QMS documentation which could save you a lot of legwork. (Make sure they really know what they are doing though!)
 
W

Woman on a mission

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.
 
D

DeviceMaker

I recommend a book that has been valuable to me in my similar position. It is:
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
Daniel, Amiram; Kimmelman, Edward
Edition: 2nd
American Society for Quality / 06-Jun-2008 / 336 pages

ISBN: 9780873897402

I hope this helps.:)
 

Wes Bucey

Prophet of Profit
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..
 
Q

QA_RA_Lady

Zak,

I agree. You can do this yourself. You DO need additional procedures IN SOME cases, but in others your QM may address most of the requirements itself. I've put together (ISO certified) quality systems that address MOST of the requirements without SOPs or sub level procedures - its possible. The consultants you spoke with are correct. Not only is 13485 the "best way to go" its the only way. CMDCAS is acheived simultaneously with your ISO cert. I.e. you don't get your CMDCAS approval without ISO. Do you have a 510k or PMA? Did you do that alone? If you were able to get FDA approval there is no reason that you can't handle ISO/CMDCAS and the MDD with no problem. What type of device do your manufacture? I know a few consultants that are reasonably priced so a less expensive consultant may be an option for you. Sounds like you jsut need a little help. If I were you I'd find a consultant that I trust. Explain your budget. Get them to come in and consult. Start with a list of questions. (Hopefully they won't charge you for a converstaion) Ask them to map out your QS or QM and work WITH YOU on everything. When the $ runs out you should have enough knowledge to continue on your own.

Hope this helps.
I'm happy to provide contacts for consulting if I can (depending on your device).... feel free to shoot me an email.
 
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