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

E-Mail s.thoren@rowiak.de


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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