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
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ROWIAK GmbH
Garbsener Landstraße 10
30419 Hannover / Germany
