Roles
NRC services focuses on support of the medical device industry.
We:
- Have specific experience with and knowledge about a broad range of (active) medical devices, processes and technical subjects (e.g. software devices, cyber security, usability, risk management, technical writing);
- Have knowledge about and experience with the implementation of MD regulatory and standards requirements for a wide variety of products and organizations;
- Transfer our knowledge and expertise towards your team, train your team on the job;
- Have an hands-on approach, involvement can be adapted to project needs;
- Have the ability to closely work in project teams with your engineers;
- Have extensive work experience in the various teams at the various levels and can adjust to the specific stakeholder position;
- Can fulfill various roles: coaching/reviewer/teaching/expert in several technical areas;
- Have the experienced to work in organizations at various stages and sizes (start-up to multinationals).
Technical Support
NRC supports you with engineering and compliance of your medical device(s). NRC supports in many processes, including but not limited to, the selection listed below:
- Design control processes, resulting in design history files / Design and development files;
- Developing regulatory strategies;
- Device classification;
- EU Regulatory filing, FDA 510(k) submissions;
- Risk management (ISO 14971);
- Electrical Safety and Electromagnetic disturbances (IEC 60601-1 general, collaterals and particulars);
- Software life cycle (IEC 62304);
- Cyber Security life cycle (IEC 81001-5-1, IEC 60601-4-5/IEC 62443-4-2);
- Usability Engineering (IEC 62366-1);
- Labeling (ISO 15223-1 + Product standards and regulations);
- Product standards (harmonized / recognized by authorities);
- Support during type test, intermediate with test houses.