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.

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IBM Jazz Platform Products.

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. 

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. 

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Testing

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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

Icon of the dashboard with graphs
Reporting & Dashboard

Status and progress tracking

Customizable live dashboard

Compliance and quality audit

Real-time metrics and reports

Image
Test
planning

Linked to requirements

Comprehensive test plan

Scope, Timeline, Resources

Risk assessment

Image
Test Construction

Requirement driven testing

Test enviroments coverage

Manual test authoring

Test lab management

Image
Test
Execution

Manual test execution

Drive test automation tools

Record test results

Submit & Track defects

Image
Reporting & Dashboard

Status and progress tracking

Customizable live dashboard

Compliance and quality audit

Real-time metrics and reports

Screens of the IBM Jazz products in action.

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

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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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
Screen of the E-Signatures in the action.
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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.

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.

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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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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

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

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Success stories of our clients

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

Whitepapers

Image

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

Image

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

Image

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

Image

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

Image

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

Image

Automating product development and compliance processes using IBM Rational software

Image

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.

Image

Drei strategische Imperativen, für effiziente und
erfolgreiche Medizintechnik Entwicklungsprojekte

Image

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

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