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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
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.
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
13485 is more rigorous than 9001, Good luck!
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