You can count on our assistance to manage regulatory affairs, digital processes, and tools. With so many years’ experience developing diagnostic and medical devices to our credit, we can provide directions at the crossroads of regulations and technological development., including risk management. We provide
- Consulting on IVDR/MDR and 21 CFR Part 820 and Part 11
- QM/QA systems implemented and optimized in compliance with ISO 13485
- ISO 14971-compliant risk management
- IEC 62304-compliant software development
- SOUP, COTS software, and tool validation with risk-based, efficient methods
- State-of-the-art cyber security delivered
- IEC 62366-compliant usability engineering services, coordinated with the development and risk management process
- Advice on how ALM tools can support digital processes
- Polarion ALM medical modules, including configurations and templates adapted and implemented to suit your processes and specifications
- Guidance on how to choose and pursue the right development approaches (agile methods, DevOps) in the regulated area
Find out more about medical consulting.