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

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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. 

Roles

The system describes roles and responsibilities which are required for 62304 Compliance process.

Predefined tasks

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.

Process description

Out of the box process description delivered as a HTML file you can adjust with processes as well.

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Design Control

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

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
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Testing

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.

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Test
planning

Linked to requirements

Comprehensive test plan

Scope, Timeline, Resources

Risk assessment

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Test Construction

Requirement driven testing

Test enviroments coverage

Manual test authoring

Test lab management

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Test
Execution

Manual test execution

Drive test automation tools

Record test results

Submit & Track defects

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Reporting & Dashboard

Status and progress tracking

Customizable live dashboard

Compliance and quality audit

Real-time metrics and reports

E-Signatures

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

 

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Engineering Lifecycle Management for Medical Devices

traceability
Reuse of requirements and tests
traceability
Development lifecycle traceability
traceability
Modeling and simulation
traceability
Automation of Compliance and Documentation
traceability
Traditional & agile practices & methods
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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.

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Benefits of using IBM EWM

Accelerate time to value

Accelerate time to value

Use the cloud to get up and running faster, so you can focus on innovation.

Bring teams together

Bring teams together

Find, fix and test work faster by linking tasks instead of using isolated, disjointed tools with fragile integration.

Simplify project reporting

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 smarter and faster

Work on the right tasks by linking plans with development and execution.

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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

Whitepapers

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Overview of the solution for medical devices and its value add for development teams. Softacus Flyer

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Improving development processes using IBM Rational DOORS Requirements Management software in Medical Devices Industry

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Accelerate development of products while meeting IEC 61508, IEC 62304, ISO 14971, ISO 13485 and 21 CFR 820.30

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Address the FDA identified lack of design controls as one of the major causes of device recalls

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How to manage your compliance with IBM Tools in Medical Device Development

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Automating product development and compliance processes using IBM Rational software

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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.

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Drei strategische Imperativen, für effiziente und
erfolgreiche Medizintechnik Entwicklungsprojekte

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Improve processes, manage IEC 61508 and IEC 62304 standards, develop quality products

Our services

we provide

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Licenses

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Installation and Setup

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Consulting

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Extensions

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