IEC 62304 Compliance with IBM ELM
Overcoming the challenge of IEC 62304 Compliance
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.
The system describes roles and responsibilities which are required for 62304 Compliance process.
The solution provides predefined activities and work breakdown structure (WBS) for activities which are required to be performed. You can then automatically generate real work assignments to your team.
Out of the box process description delivered as a HTML file you can adjust with processes as well.
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.
Traceability and Transparency
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.
Linked to requirements
Comprehensive test plan
Scope, Timeline, Resources
Requirement driven testing
Test enviroments coverage
Manual test authoring
Test lab management
Manual test execution
Drive test automation tools
Record test results
Submit & Track defects
Status and progress tracking
Customizable live dashboard
Compliance and quality audit
Real-time metrics and reports
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.
- Name of the signing Person
- Reason for signing
- Signature date
- Specific custom text
- Approval comment
Engineering Lifecycle Management for Medical Devices
Automate Your Validation and Verification
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
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.
Benefits of using IBM EWM
Accelerate time to value
Use the cloud to get up and running faster, so you can focus on innovation.
Bring teams together
Find, fix and test work faster by linking tasks instead of using isolated, disjointed tools with fragile integration.
Simplify project reporting
Stay on top of activities and overall progress with simple, automated cross-project reporting that provides a single view of the truth.
Work smarter and faster
Work on the right tasks by linking plans with development and execution.
ISO 14971 Risk Mangement for Medical Devices
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
Overview of the solution for medical devices and its value add for development teams. Softacus Flyer
Improving development processes using IBM Rational DOORS Requirements Management software in Medical Devices Industry
Accelerate development of products while meeting IEC 61508, IEC 62304, ISO 14971, ISO 13485 and 21 CFR 820.30
Address the FDA identified lack of design controls as one of the major causes of device recalls
How to manage your compliance with IBM Tools in Medical Device Development
Automating product development and compliance processes using IBM Rational software
This paper will explore what IEC 62304 compliance means for manufacturers in some detail, and also describe the larger context of systems and software engineering best practices at work in many of today’s most successful companies.
Drei strategische Imperativen, für effiziente und
erfolgreiche Medizintechnik Entwicklungsprojekte