Medical Devices

The development of medical devices is driven by risk identification and mitigation. Ensuring that devices fulfil the safety requirements defined in standards such as IEC 60601, ISO 14971, IEC 62366 and IEC 62304 is a major challenge. Planned changes in the medical device sector in the coming years will make this a time consuming exercise for an increasing number of medical device companies. Identifying potential risks in devices, systems, hardware and software is a complex process, as is the implementation of the corresponding mitigations.

We can help you reach these goals through our years of experience in hardware and software development in the medical sector. We have gained an in depth knowledge of not only the current normative standards but also of forthcoming changes to these standards.

Standards:

  • Safety IEC 60601-1, plus collateral and particular standards
  • Risk Management ISO 14971
  • Usability / Human Factors IEC 60601-1-6, IEC 62366, ANSI/AAMI HE75
  • Software IEC 62304 / 82304
  • Cybersecurity AAMI TIR57 and other sources
  • Quality Management ISO 13485 & FDA 21 CFR 820
  • EU Medical Device Regulation and Directive

Services:

  • Risk management
  • Requirements management
  • Quality management
  • Hardware reviews
  • Failure Modes and Effects Analysis (FMEA)
  • Fault Tree Analysis (FTA)
  • Embedded software reviews, including architecture, tool selection and metric compliance
  • Generation of all relevant work products, reviews and reports

Expertise: