Clear View on Regulatory Affairs

Before you can bring your medical device to the market, you need to pass through a complex landscape of regulatory requirements. We provide guidance to navigate your through this jungle. 

You benefit from our many years of experience in developing ophthalmological medical devices and conducting own clinical studies, as well as from our large contact net and cooperation partners in the field of ophthalmology. 

Our regulatory expertise includes:

Preparation and maintenance of technical documentation

Defining the intended purpose and use requirements of the device

Determine requirements of the device, including software requirements

Research of applicable product standards

Risk management according to EN ISO 14971

Risk Classification

Software Safety Classification

Support with Clinical Evaluation

Systematic literature reviews

Support in planning and coordinating clinical investigations, including the submission of the application to the ethics committees and BfArM

Medical and technical writing

Proof of compliance with MDR Annex I general safety and performance requirements

Support for the submission of approval documentation

Your contact person


Sandra Thorén PhD

Phone +49 511 277 2960


No time to call right now? We will be happy to call you back. Just leave us your name and phone number here.

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