Quality and Approval
As a manufacturer of medical devices, we are familiar with the admission requirements for such devices and are your competent partner for all approval questions.
We assist you with procedures in the EU and the US and are prepared to help you with the implementation and maintenance of your quality management system.
The range of services includes:
Advice on approval-specific questions during product development
Standards and patent research
Compiling of technical documentation / technical dossiers and review of existing documents
Support related to risk management (DIN EN ISO 14971), SW development process (IEC 62304) and usability (IEC 62366-1)
Communication with test laboratories and Notified Bodies
Check for compliance with the essential requirements according to MDD / MDR
Preparation of regulatory approval applications
Classification of the medical device
Regulatory compliant compiling of technical documentation in accordance with EU directives or for a FDA 510 (k) procedure
Set-up of the product file or the DMR
Support in setting up and maintaining a quality management system
FMEA and risk assessment
Technical Due Diligence procedures
Preparation of clinical evaluations
Project inquiry
Please contact us and we will be happy to prepare an individual project concept for you.