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Our services

Unitron Regulatory is the right partner for product certification in the field of medical devices and life-science devices.

Our team has specialist knowledge and practical experience with regard to product certification (CE, MDD/MDR, IVDD/IVDR, LVD, FDA, etc.) of medical and life-science electronic products and equipment. We are experts in the field of building up a technical product file and product life cycle management.

Our services

Do you need advice or assistance with the certification of your electronic device? Don’t hesitate and contact us!

Technical Documentation

Unitron Regulatory offers support in building your technical documentation.

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Regulatory Advice

We know about the EU regulatory framework for active medical devices.

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Regulatory Support

New to the industry or experienced? Either way, regulatory demands can be overwhelming.

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Product Life Cycle Management

Once placed on the market, the product and its documents shall stay 'state of the art'.

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