D
danush
Hello all,
My company is about to submit a design dossier for CE marking together with ISO 13485 certification. in case we want to simultaneously get certified for Canadian ISO 13485, I have several questions:
1. Do we need to have additional tech file complying with Canada MDR for the audit?
2. Clinical data type- for CE mark we conducted a literature survey on devices considered equivalent to our device. Would it satisfy Canadian MDR or do we need to conduct actual clinical invetsigation before we can apply for Canadian license?
Thank you.
My company is about to submit a design dossier for CE marking together with ISO 13485 certification. in case we want to simultaneously get certified for Canadian ISO 13485, I have several questions:
1. Do we need to have additional tech file complying with Canada MDR for the audit?
2. Clinical data type- for CE mark we conducted a literature survey on devices considered equivalent to our device. Would it satisfy Canadian MDR or do we need to conduct actual clinical invetsigation before we can apply for Canadian license?
Thank you.