IEC 62304

Software Certification for Medical Devices

Sophisticated medical devices have to be certified according to IEC 62304, the standard for functional Safety in the Medical industry. The appliances are more and more used directly at the patient and have to prove a safe and sufficient operation, as software is often an integral part of Medical devices technology.

IEC 62304 Certification Standard

Functional Safety in the Medical & Healthcare industry is certified according to IEC 62304, a standard for the software life-cycle processes of medical device software, released in 2006. IEC 62304 requires Safety software classification and defines processes for software development, maintenance and risk management, configuration management, problem solving processes, and quality management. The IEC 62304 standard classifies three Safety classes.

Safety Classes

  • Class A - no risk
  • Class B - no serious injury
  • Class C - risk of death or severe injuries

Reducing Time-to-Market via Safety CertKits

The PikeOS certification approach is modular and hardware independent to the upmost extend. Certifications can be easily extended to different hardware platforms with additional certifiable artefacts, such as a certifiable IP stack, POSIX, Math Library or a filesystem. The tool chain is qualified and the Safety methods and considerations are adapted accoring to the respected vertical market. PikeOS is certifiable according to the latest industry certification standards. We engage in a close manner with major homologation institutes. The CertKit supports the certification process of the entire system, thus reduces time-to-market. PikeOS comes with requirement documents (all hierarchy levels) that are structured by requirement IDs and can be reused in customer documentation for traceability.

Other standards can be met via compliance matrices.

The PikeOS Certkit is a bundle of evidences for a specific PikeOS version and hardware.
It contains:

  • Software Accomplishment Summary for PikeOS
  • Software Accomplishment Summary custom BSP (if any)
  • Safety Manual for PikeOS
  • Safety Manual for selected Architecture
  • Tool Qualification Report
  • Tool Operational Requirements of customer-related tools  
  • Interface Specifications
  • User Manual

Each CertKit comes with a frequently updated Safety bulletin, mentioning known Safety alerts and improvements. Customers can switch to long term maintenance for a selected certifiable product.

PikeOS Safety Technology

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