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Quality Assurance & Regulatory Affairs
At Circum Medtech Pharma, our QARA team offers you the best-in-class support in order to help you obtain your CE mark and other international registrations.
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In the current environment we provide our customers with our expertise and help them to minimise the time period to get their MDR approval as fast as possible.
Our QARA team will help you with the following deliverables:
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510k submissions
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Regulatory strategy
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CE Mark technical files
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CE / UK / CH rep services
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Clinical Evaluation Reports
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Biological Evaluation Reports
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Other international registrations
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Partnership with Notified Bodies
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MDSAP best roots: Canadian Market
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Sterilization (ETO, Gamma, Beta) validations.
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