When engineering medical devices, compliance with international standards is a fundamental requirement. Medical devices often contain software-controlled applications, the failure of which could result in death or serious injury to the patient.
Software development is an integrated part of the production of medical devices. Therefore traceability and software quality assurance are ranked as top priorities for manufacturers of& medical devices. Processes along the application development lifecycle must be compliant with IEC 62304 and exceed those required standards.
Medical ALM applications must be able to support standardized procedures based on the required healthcare standards and regulations. Intland Software's preconfigured Medical IEC 62304 & ISO 14971 Template not only meets those requirements, but can also be easily adapted to your needs. This template has been developed with medical domain experts to support any proprietary process or development environment in the innovation of medical technology.
Three main highlights of Intland’s Medical IEC 62304 & ISO 14971 Template
Allows you to flexibly visualize any and all dependencies across requirements, risk and test cases trackers, or any other work item.
Risk trackers & Risk Matrix Diagram
Dedicated risk trackers are available to store and manage product risks and hazards, as well as associated requirements and test cases. Highly flexible risk management workflows support the fulfillment of systematic risk management processes and monitoring along the whole development lifecycle. A Risk Matrix Diagram helps you visualize your overall risk levels.
This template's medical wiki is a knowledge base on IEC 62304 and ISO 14971, equipped with process descriptions, document templates, risk & requirements management rules, test and Quality Assurance process definitions, and description of how the template supports each requirement of relevant medical standards.
For more info, get in touch for a 1-on1 product demo, or simply request Intland’s Medical IEC 62304 & ISO 14971 Template!