be-on-Quality your partner for reliable regulatory results.
The be-on-Quality Team:
We are experts for medical devices and in-vitro diagnostics, specializing in quality management, regulatory affairs, and clinical affairs.
Our Vision:
To develop sustainable solutions individually tailored to the needs of our customers.
We support manufacturers in all regulatory questions from the initial idea, approvals and registrations to market access and beyond.
Our Mission:
To support our clients with regulatory strategies and to implement efficient and effective processes to ensure the quality and safety of medical devices.
Our Portfolio of Services includes:
- Implementation of a quality management system according to ISO 13485 and MDR/IVDR
- Support for conformity assessment according to MDR/IVDR
- International registrations
- Advice on setting up a regulatory and clinical strategy
- Implementation of 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 courses
