Regulatory Affairs
The approval of medical devices is a complex subject that covers a multitude of areas and poses a challenge for those placing medical devices on the market. Attention must be paid not only to pan-European laws and regulations, but also to specific legislation of the individual Member States. Various applicable standards must be identified and fulfilled, in regards to the product documentation in itself, but also in regards to quality management in the company. Subsequently, it is vital to monitor the continuous changes in the legislation, and to keep the existing documentation up to date and compliant.
The employees of MDSS Consulting GmbH offer extensive experience in interpreting and implementing regulatory requirements worldwide. With our consulting services, we safely navigate your company through the jungle of laws, standards, guidelines, and regulations.
- Regulation (EU) 2017/745 (MDR) & Regulation (EU) 2017/746 (IVDR)
- UDI labeling
- CE Marking
- Conformity Assessment
- Quality Management
- Risk Management
- Technical Documentation
- Person responsible for regulatory compliance (PRRC)
- Internal and external audits and supplier audits
- GMDN-Code Research
- Training
- Research of Standards