Medical devices, use scenarios, technologies
- Surgical instruments (HF, laser),
- Radiation therapy (gamma, electron, proton),
- Robotic surgical platforms,
- Imaging (x-ray, ultrasound, MR),
- Surgical navigation (IR, EM),
- Physiological monitors,
- Active implants, and
- IVD devices.
- Safety, IEC 60601/ISO 80601 series,
ISO 14708 series, IEC 61010 series;
- Risk, ISO 14971;
- EMC, IEC 60601-1-2, IEC TR 60601-4-2;
- Software, IEC 62304; and
- Usability, IEC 62366.
Helping our clients through risk management and compliance issues from design to implementation.
Verifying your design to applicable standards.
Explaining the complexities of integrating medical device safety into your design process, equipping your team with the tools they need to move forward.