Intland’s Medical IEC 62304 Template: Develop High Quality & Compliant Medical Devices
Software quality, safety and reliability are crucial when it comes to medical systems development. Malfunctioning medical devices can cause serious injuries or even death to patients. This explains why a reliable ALM software solution offering all-round lifecycle functionality and full traceability is essential to developers of medical devices.
Intland’s Medical IEC 62304 Template leverages the advanced capabilities of codeBeamer ALM to address the special needs of medical device developers seeking compliance with relevant standards such as IEC 62304, FDA Title 21 CFR Part 11, IEC 60601, and ISO 14971.
Intland’s Medical IEC 62304 Template offers several useful features and capabilities including:
- Preconfigured medical requirements to specify and manage your requirements.
- Integrated architecture & single repository to establish links between requirements, source code and test cases as well as regulatory compliance (audit) documents and reports.
- Traceability Browser and Matrix to show dependencies between artifacts (requirements, risks) and to visualize, and easily pull & export traceability reports for compliance audits.
- Medical wiki to support compliance with IEC 62304.
- Preconfigured but customizable workflows for the enforcement of processes and rules throughout the entire medical device development lifecycle.
- Risk management to identify, prioritize, and control risk-relevant data including severity, likelihood, current risk controls as well as planned mitigation actions.
- Risk Matrix Diagrams to visualize the overall risk.
- Release Management to plan activities, iterations and releases (milestones, versions), with estimated time and effort and monitor the progress of all development.
- A preconfigured Failure Mode and Effects Analysis (FMEA) template to conduct Failure Mode and Effects Analysis and an FMEA Worksheet that is exportable in several formats.
- Medical Quality Assurance & Testing to define and execute test cases, build test sets and create test libraries for later re-use.
For more information and access to Intland’s Medical IEC 62304 Template, please fill in the following form.