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 consultancy team of MDSS Consulting GmbH offers many years of experience in the interpretation and implementation of regulatory requirements worldwide.
Thanks to our consulting services, we guide your company safely through the jungle of laws, standards, directives and regulations.
- MDR & IVDR
- UDI labeling
- CE Marking
- FDA Device Registration and Listing
- Conformity Assessment
- Quality Management
- Risk Management
- Usability
- Technical Documentation
- Safety Officer and Vigilance
- Internal and external audits
- GMDN-Code Research
- Training
- Research of Standards