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Scandinavian Regulatory Services


Medical Devices


With our experience of building quality systems compliant with US 21 CFR 820 Quality System Regulations, as well as EN ISO 13485, we offer the support you need in this aspect.

It could be preparatory work for a notified body or FDA inspection, setting up parts of the quality system, provide strategic input to your system or even building a full quality system.

Please feel free to contact us to discuss your needs.

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