Medical Devices

Whilst the tools we use are software based, because of their dynamic nature many aspects are equally relevant in a wider context. For instance, any medical device must be properly specified to enable it to be validated for regulatory approval. Test definitions and hazard analysis must be linked to specification to ensure completeness and a quality system must be employed.

EN 62304

Software, either embedded as part of a medical device, or software which is itself deemed to be a medical device should be developed in compliance with ISO EN-62304, which defines the minimum requirements for the medical device software development lifecycle. The demands differ according to the safety class of the device. Devices that either inject energy or help to control life-critical function must conform to higher standards of design strictness than those which merely record information.

Process

To help our customers to ensure regulatory compliance while reducing business risk we have developed the TraceIT® quality process which combines a strong, tried and tested software process with the requirements of EN-62304. The process is a development of the Unified Process. We provide a concise definition of the process including the extensions required to meet the requirements of ISO EN-62304. This is supplemented with Guidance notes, which provide advice about how to implement aspects of the process where there is likely to be a need for interfacing with a manufacturer's established practice.

Quality systems

The medical device development lifecycle must be must be predicated on a quality system compliant with ISO 13485. Automating this quality system and other aspects of software development brings a range of benefits:

  • By ensuring compliance reproducibly, it reduces paperwork, allows production of regulatory documentation as a matter of course and ensures that responsibility for decisions right through the production cycle is clear and can be recovered in a subsequent audit.
  • Automated tracing is responsive to change when this becomes necessary by helping identify those parts of the system that are sensitive to a specific change and reducing the need to rework traceability information.
  • Model Driven Development (MDD) provides a fast and reliable route to develop systems, which may be deployed in a way that assists in generating required documentation. MDD also helps by creating a basis for the evaluation of prototypes at an early stage in the development cycle.

We discuss the techniques that we employ more fully in our range of white papers and our article published in European Medical Device Technology magazine.