9/24/2023 0 Comments Iso 13485 registrar![]() The best way is to find out which registrar has a local presence. Pricing also depends on the complexity and classification of the device. One factor that can reduce your costs is having a local auditor which can cut done on travel and hotel costs. There is not much lee-way in terms of pricing. There are several labs in Canada that provide better service than the certification body. It may be useful to get an independent lab to perform testing to IEC 60601-1 since they may be closer and more responsive to your needs. ![]() ![]() If you want to get CE marking then you need a CB who is a notified body and based in Europe. Click to expand.You can only select the CB that have been approved by Health Canada in order to get CMDCAS approval and sell in Canada.
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