We are experts in medical devices and in vitro diagnostics, specializing in Quality Management, Regulatory Affairs, and Clinical Affairs.
Our Vision:
Developing sustainable solutions tailored to the individual needs of our clients.
We support manufacturers with all regulatory matters from the initial concept through all approvals and registrations.
Our Mission:
Supporting our clients in navigating regulatory challenges.
Implementing efficient and effective processes to ensure the quality and safety of medical devices.
Our service portfolio includes, among others:
- Implementation of a quality management system according to ISO 13485 and MDR/IVDR
- Support for conformity assessment under MDR/IVDR
- International registrations
- Consulting on regulatory and clinical strategy development
- Conducting audits
- Preparation of technical documentation, including:
- Risk management
- Usability engineering
- Software documentation
- Clinical evaluation
- Biological evaluation
- Post-market surveillance reports
- Consulting on standards such as IEC 60601-1, IEC 62304, and IEC 62366
- Training