Engineering Lifecycle Management for Medical Devices

Develop medical devices with high quality by leveraging reuse concepts, collaboration, traceability, and full compliance to medical standards

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As devices become more complex and connected, IBM helps you develop on timeto budget, and safely every time

As regulations increase complexity and add more risks to a project timeline, IBM helps to comply with regulations like IEC 62304, FDA Design Controls (21 CFR P. 820.30), FDA electronic records & signatures (21 CFR P. 11).

As new business models emerge from acquisitions and merges, or from new technology trends like IoT, blockchain, 3D-Printing, etc, IBM helps you implement innovative ideas, new functionalities integrally via managing changes and digital transformations into your products and services.

As patient-centricity drives customizations, and eventually evolves into variations and versions of products, IBM helps you effectively manage versions and variants in your projects. … Just like we support many other companies from other complex industries

Engineering Lifecycle Management for Medical Devices

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IBM Engineering for Medical Devices consists of a set of process assets (modifiable by the customer using Rational Method Composer), which include workflows deployable in Rational Team Concert. It also includes a DOORS project template for medical devices, which contains pre-defined DOORS modules that users can instantiate to deploy DOORS more quickly in projects required to comply with FDA QSR and IEC 62304.  The DOORS modules contain a set of defined attributes for the various stages of development in the safety lifecycle, including specification, design, implementation, integration, verification, validation, and production release. A version of this template is also available for DOORS Next Generation.

Softacus solutions based on IBM ELM for Medical Devices

1.

Softacus provides an integrated solution for teams developing medical devices to collaborate throughout the entire product development lifecycle. Product and portfolio management help to analyze and prioritize the various market requirements to help plan the right product to build.

Manage the requirements to ensure there is traceability to the design implementation providing an audit trail for regulatory auditors with reporting capabilities to help in the submission documents.

3.

Our solution provides the ability to automate the generation of submission documents showing your requirements and design information to deliver consistent and complete documentation. And if a change occurs rapidly update the documentation that accurately reflects the design.

Finally, the solution creates a central repository for teams to manage quality and test assets that promote an early focus on identifying quality problems early and avoiding costly recalls.

2.

Medical device development teams can visualize the requirements and implement them directly using a modeling-driven approach which strengthens the audit trail further by tracing architecture and design back to requirements. Because the implementation is generated from the model, consistency is maintained automatically between the implementation of the device software and the documentation of the device. The implementation and documentation are automatically synchronized. Furthermore, it promotes an iterative development approach that enables early validation of the design through execution and test early.

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Features and ways how
we can help you to
achieve compliance.

IBM Requirements Quality Assistant

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Watson capability embedded inside DOORS Next Generation (DNG)

  • Removes risk and ambiguity in the requirements authoring phase out-of-the-box by using AI (Watson Natural Language Understanding)
  • Pre-trained to detect key quality indicators designed to be consistent with the INCOSE Guidelines for Writing Good Requirements
  • Authors receive coaching from Watson to improve the quality of the requirement as it is being written.

Failure Mode and Effects Analysis

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IBM provides out of the box FMEA extension for IBM Jazz Platform which is installed in /RM component. Extension enables users to:

  • Choose attributes like probability, severity, impact
  • Automated or manual calculation of risk priority number (RPN)
  • Linking of FMEA artifacts to affected requirements and to mitigation requirements
  • Out of the box Gap Analysis

With help of Softacus FMEA extension we are also able to:

  • Compare RPN before and after mitigation
  • Color-code RPN based on the value
  • Adjust the FMEA calculation to any of your needs
  • Provide it for free to our IBM Jazz customers

Hazard Analysis
Fault Tree Analysis (FTA)

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  • Traceable links among requirements, Traceable links among requirements, analysis, design, and safety elements makes your “safety case”
  • FTA elements can have traceable, navigable links to– Requirements– Elements that can manifest faults– Elements that can detect faults– Elements that handle faults
  • FTA elements contain metadata– Severity– Likelihood– MTBF– Risk– Safety Integrity Level
  • UML Fault Tree Analysis Profile
  • Fault Means, Effect, and Criticality Analysis (FMECA)
    – An inductive (bottom-up) approach that relates component faults with hazards
    – Cannot be applied until you have a parts list, which is late in the development process
  • Security Analysis Diagram
    – UML Profile for modeling cybersecurity, threats, and countermeasures

Industry leaders are using IBM ELM solutions

traceability
10 of Top 10

Aerospace & Defense Companies

traceability
10 of Top 10

Automotive Manufacturers

traceability
10 of Top 10

Smart Phone Manufacturers

traceability
9 of Top 10

Medical Device Manufacturers

traceability
9 of Top 10

Pharmaceutical Companies

traceability
8 of Top 10

Semiconductor Companies

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

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Softacus s.r.o.

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Fax: +41 43 344 6075

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