As originally asked by Olufemi Adeoye.

Can someone provide me with estimates on how much ISO 13485 registrar (CMDCAS for Canada) and EU notified bodies charge for certification as well as how long it takes; considering
1) Specification developer/Authorized representatives (non-manufacturing) with 10 to 15 employees, 2) Manufacturer with 50 to 100 employees and 3) Manufacturer with 100 to 200 employees. Thanks

Bruce Youngman
Dedicated to improving value
I agree with Robert and start with the Health Canada link for their listing of approved CMDCAS registrars as it will narrow your search considerably. Quotations I have received so far from a variety of registrars have ranged from just under 10,0000 USD with around a $3800 USD annual surveillance audit expense. Travel expenses extra. The other end of the scale so far has been $15,500 USD with a $6000 annual surveillance audit expense. These were quoted for a single site certification with less than 50 employees. CMDCAS adds another half day or so of auditing so add around $1000-$1500 for that certification. You may also gain other certifications such as ISO 9001 with “minimal” expense.

Steve Bixby
Director, International Sales & Marketing at MorTan, Inc.
I think the fees mentioned above are correct, especially when you figure in additional fees. We deal with a company that charges only $1250 per day, with a two day initial audit followed by one day audits for the next two years (and then the cycle starts again). However, we also pay the auditor’s travel expenses as well as a fee to the Notified Body for our certificate ($800 I believe) each time we do the recertification.

Also, you might check how often the recertification audits need to be done. I don’t know if it varies, but for me it’s every 3 years for ISO 13485/9001 and every five years for the CE mark (with two day audits needed for the recertifications). Quite a racket.

One other thing: it’s expensive to switch, especially for your CE mark as you’d have to change the registrar’s number on your labeling. Unfortunately, the auditor may be more important than the company (I once had a guy that measured the distance between the letters C and E in our CE mark…) so it’s hard to know in advance if you’re going to like the company.

Rob Packard
510(k), CE Marking & Quality System Consultant
HI Olufemi. I think of there being three tiers of certification bodies. The top is a larger Notified Body. The daily rate is around $2,500 USD for auditing of the QMS, and $3,500 for the Technical Review of Dossiers for CE Marking. The second tier is smaller Notified Bodies. They may be below $2,000 USD per day, and the auditor for the QMS. The Dossier review is likely to cost less too. The third tier is a certification body that cannot issue CMDCAS Certification or a CE Certificate.Since you want CMDCAS, I would refer to the Health Canada Recognized Registrar list as your starting point: [http://bit.ly/RecognizedRegistrars|leo://plh/http%3A*3*3bit%2Ely*3RecognizedRegistrars/QLXh?_t=tracking_disc]. Then you can narrow this down by determining which registrars can also issue a CE Mark for the type of device you are making.

The process of certification and CE Marking can take anywhere from 3 months to 12 months, but 6 months is typically an aggressive goal. For the number of days of auditing for certification, the Stage 1 audit will be 1 day. The Stage 2 audit will be balance of the days required by the IAF MD9 Standard. There are different cut-offs for # of days and they don’t match up with your three choices exactly.

Robert J. Steele
Director of Service Solutions at Agiliti
In general the audit will typically cost $5-15K (sorry I only know the amounts in USD). There are a range of factors in that decision, the total cost is more related to the maturity of the quality system itself as opposed to the number of employees in the ranges you asked about. You can spend a lot or a little on the preparation for the audit. This is where the key dollar and pain point exists, but leadership will have to embrace the process and everyone will have to own it to be successful. If you pass without major non-comforties that would prevent certification it should take a few months to gain your certification, but that is assuming the time has been spent up front to ensure a successful audit.

13485 is more rigorous than 9001, Good luck!