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Medical manufacturers faces many challenges in accessing international markets efficiently and safely, while meeting their business targets and the regulatory requirements of each geographical area.

DEDICATED SERVICES

We offer technical documentation review services in order to help you achieve your goals of bringing medical devices to market in a timely and cost-effective manner.

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Let's discuss how we can work together in the CE marking process of your medical devices.

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TECHNICAL DOCUMENTATION

As required by regulations on medical devices, it must meet the applicable regulatory requirements before being placed on the market.

It is the responsibility of manufacturers to ensure that their medical device complies with all safety and performance requirements of the CE mark. The manufacturer must address each requirement and submit evidence demonstrating compliance.

KEY STEPS TO FOLLOW

– Ensure product compliance with all applicable EU-wide requirements.
– Determine whether the manufacturer itself or an external body will assess the product.
– Compile a technical file proving the conformity of the medical device.
– Draw up and sign an EU declaration of conformity.

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