IEC 62304 Compliance with IBM ELM

Learn how IBM ELM helps you achieve compliance with the international standard IEC 62304 to satisfy all your workflow needs.

Learn more about IBM ELM for Medical Devices Development

Software Development in the age of innovation and progress is causing market disruption and brings many growing concerns such as: 

• Concerns over Cybersecurity
• Software becoming rapidly more Complex
• Requirements for Regulatory Approval
• Need for fast delivery, decision-making, and deployment

While still being able to contain all the costs, market release, and maintaining the quality at the same time. While the risk of failure is high, overcoming the challenge of IEC 62304 Compliance can help you succeed. 

Design Control provides delivery processes, work tasks, work products, process roles, and guidance that support the objectives, plans, tasks, and work products described and specified by the US Food and Drug Administration (FDA) Design Control Guidance for Medical Device Manufacturers.

This mapping aids the development of devices by providing links between the standard and the process assets that are represented within the Rational Practice library and processes.

Specific guidance is given on the application of IEC 62304 which covers software development processes for medical devices. Support is provided for customers to carry out Intended Use Validation of DOORS in the context of their processes.

Solution Web site (.war)

RTC 6.0.6 Process Template

Achieve IEC 62304 compliance with Requirements traceability. IBM ELM offers great help with the support of Software Requirement Analysis by tracing software requirements to its parent requirements, while also linking to test cases and test procedures with other features like:

• View of every important object in a single place
• Development progress transparency
• Project Linkage to Department standards
• Identification of issues for Work items needing Attention

Traditionally, testing was generally treated as a separate activity that was only triggered at certain points in a development process. A more modern approach to systems and software development involves continuous validation throughout the development lifecycle. This is ideal for meeting standards such as IEC 62304, because it helps to verify that requirements are met at every phase in the process.

Sign specific configuration of your specification (baseline) with electronic signatures compliant with CFR Part 11 process from the FDA.

The signatures can also be captured, and the information can be printed into a document.

Example:

• Name of the signing Person
• Reason for signing
• Signature date
• Role
• Specific custom text
• Approval comment

Validation and verification is supported via comprehensive traceability, automated forensic-level accountability, and real-time reporting throughout the lifecycle as well as across projects.

Furthermore, it is supported via review and approval of any work item with an electronic signature, combined with uninterrupted traceability starting at the design phase.

Rapid Product Development of your products are greatly accelerated by IBM Engineering Workflow Management, which acts as the critical link between required and delivered work by enabling teams to manage plans, tasks and project status. 

It provides the flexibility to adapt to any process, so companies can adopt faster release cycles and manage dependencies across both small and complex development projects.

IBM ELM provides support in compliance for ISO 14971 by providing key features that help you and your team throughout your process of designing Medical Devices such as:

• Collaborative Risk Analysis
• Intended Use Validation
• Configurable KPI Dashboards
• Integrated CAPA System

Read more about our support for ISO 14971 Risk Management for Medical Devices in IBM ELM