IEC 62304 sets the framework for managing the software development lifecycle of medical devices. Compliance ensures that the software used in medical devices is reliable, safe, and meets regulatory requirements. Achieving compliance not only guarantees the quality and safety of your product but also facilitates market access and regulatory approval.
The Role of Tento+ in IEC 62304 Compliance
Tento+ offers a comprehensive set of features that streamline the process of achieving IEC 62304 compliance. Let’s explore how this tool can be your invaluable ally in this endeavor:
- Design Standard Identification: Begin your compliance journey by using Tento+’s Design Standards Discovery Tool. This tool automatically identifies the design standards applicable to your device, including IEC 62304, ensuring that you are aware of the relevant requirements from the outset.
- Requirement Management: Tento+ simplifies the management of requirements by allowing you to define, track, and link requirements at various levels. This ensures that your software development aligns with the specific requirements of IEC 62304.
- Configuration: Tento+ allows you to take snapshots of versions, and up-issue your device as the product evolves.
- Traceability: Achieving traceability between requirements, design outputs, and specifications is a key aspect of IEC 62304 compliance. Tento+ offers visual traceability features that enable you to map and track these elements effortlessly.
- Anomaly Management: Compliance requires diligent anomaly identification, tracking, and resolution. Tento+ provides an Anomaly Management Tool that streamlines this process, ensuring that anomalies are promptly addressed and documented.
- Test Planning and Execution: IEC 62304 mandates comprehensive software testing. Tento+ simplifies test planning, execution, and results tracking, helping you meet the rigorous testing requirements of the standard.
On top of these, you’ll also need SOPs that describe how your team works and how they handle software problems, deployment, and source management. If you are looking for hands on advice, head to our programmes page, and we will get you 62304 Compliant in 4 Weeks.