Regulatory Affairs: Market launch of medical devices without difficulties
Solnovis is your competent consultant in the area of Regulatory Affairs and Quality Management in each project phase. We combine wide experience in the field of medical technology with sound consulting competence.
Several steps are necessary for the launch of medical devices. The requirements depend on the target market and the local regulatory and standards requirements. We support your certification process (CE, US and international) and help you to prepare for external and internal Audits.
Our solution-based strategies enable a cost-effective, efficient and prompt realisation of the particular project.
Our services at a glance:
- Consulting on quality management (EN ISO 13485, EN ISO 9001, 21CFR820)
- Definition and optimization of Standard Operating Procedures
- Preparation for external audits (FDA, Notified Bodies, authorities)
- Preparation and carrying out of internal audits
- Regulatory documentation for submissions
- Licensing of medical products (CE, USA and international)
- Risk management according to ISO 14971
- Software documentation according to IEC 62304
- Usability evaluation according to IEC 62366
- Safety of medical devices according to IEC 60601-1-ff and IEC 60601-2-ff, especially in the areas of electrical safety and EMC