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Medical Device Industry - IEC 62304 - Software Lifecycle Processes

In today's high tech devices, reliance on software for new features and innovations has increased dramatically. Some engineering companies cite software for up to 70% of their new features and product differentiators. The Medical Device industry is no exception to this trend, and the development of this software is complex and consumes a large part of project budgets. As the proportion of software increases in medical devices, so does the complexity of managing that software.

IEC 62304 prescribes standards for managing the software lifecycle for medical devices. It is a strict standard that can increase development overhead significantly, but conformance with this standard provides evidence of having a software development process in place that fulfills the requirements of 21CFR820 and the Medical Device Directive 93/42/EEC.

MKS Integrity is ideally suited to manage the software lifecycle through robust capabilities for Software Configuration Management, Change Management and traceability between software components and design or validation and verification records.

  • Software Configuration Management – Speed time to market with support for software reuse, support geographically distributed software teams with MKS Integrity and its Federated Server Architecture, and enable compliance with requirement 8 of IEC 62304 relating to Software Configuration Management process.
  • Change Management – Improve communication and visibility through task based software change management. This change management capability of MKS Integrity supports requirement 8.2 of IEC 62304 which is the support for change control including approval, implementation and verification.
  • IDE Integrations – A core strength of MKS Integrity is its ability to support cross-platform development with deep integrations into multiple integrated development environments, or IDEs. These integrations allow software engineers to access version control, change management and requirements management without ever having to leave the development environment, regardless of whether a software engineer is working within Eclipse or Microsoft Visual Studio. 
  • Software Risk Management – With support for ISO:14971, capturing software components in MKS Integrity extends the risk management concepts of hazard analysis, risk analysis and risk control to apply to software components. This meets several requirements of Clause 7 of IEC 62304, for Software risk management process and ensures that software risks are being assessed with the rigour of overall product risks.
  • Software Safety Classification – By identifying software components as items in MKS Integrity, organizations can classify those software components based on the IEC 62304 requirements for safety classification. This identifies components or systems of software as Class A: No injury or damage to health is possible, Class B: Non-SERIOUS INJURY is possible or Class C: Death or SERIOUS INJURY is possible. The classification of software components specifies the requirements of IEC 62304 that must be met for that component or system. MKS Integrity provides the ability to enforce requirements such as risk management of software based on the safety classification specified.

Table A.1 of IEC 62304 – Summary of requirements by software safety class (Source: IEC 62304:2006)


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