codebeamer-alm-medical-industry Requirements, Risk, and Test Management for Medical Device Developers

Deliver quality digital health products with Codebeamer X

Mature design control for medical software development, quality process & audit management, and comprehensive risk management – all in one tool.

Achieve product and process design maturity. Deliver better quality outcomes, and make medical device product quality a source of competitive advantage. Shorten design and development cycles, reduce quality costs, and accelerate regulatory certification.

Use Codebeamer X as a global, shared electronic system for quality, development, risk management, and approval processes in the delivery of digital medical devices. Implement a comprehensive quality management system, improve quality performance, and design clinically effective MedTech solutions that improve the patient experience.

Save configuration time and compliance effort using our preconfigured Medical Software Engineering Template and Medical Audit & CAPA Template.

Medtronic Customer Case Study

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Benefits of Codebeamer X for Developers of Digital Health Products

Integrated product delivery

Align the design and development processes of medical device hardware, software, and service components. Manage the impact of changes across the lifecycle. Give your teams a platform to collaborate efficiently, channel feedback into design decisions, and maintain focus on quality as delivery accelerates.

Full risk management & audit support

Gain confidence in asserting compliance with medical device regulations. Guarantee the early and adequate management of risks, and execute FMEA conveniently. Achieve transparency, traceability, and accurate documentation along product delivery. Manage approvals, export custom audit reports, and simplify design and product verification and validation.

Agility in regulated development

Provide freedom for your teams, and confidence for your auditors. Enforce the use of controlled processes to enable Agility in full adherence to medical regulatory requirements. Accelerate the delivery of medical technology, and assert compliance with minimal effort.

Intland’s Templates for Health Tech Development

Our predefined templates contain baked-in configuration for codebeamer X to suit MedTech regulatory requirements. Access industry best practices and compliant processes out of the box to cut project time, costs, and risks!

Learn more about MedTech Templates

Features for Medical Device Development

Medical Device Requirements Management

Specify, manage, and document your requirements throughout the device’s development lifecycle in collaboration with all stakeholders. Manage changes in related requirements with automated suspected links notifications. Accommodate changes transparently using the collaborative Review Hub, and customizable, compliant approval processes (with timestamped e-signatures). Navigate the impact of changing requirements with ease, and automatically notify relevant users. Provide user groups of all disciplines and permission levels with straightforward access to up-to-date specifications. Establish traceability between requirements and all upstream and downstream artifacts, regulatory documents, and audit reports.

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Embedded Software Development and Release Management

Integrate hardware with software delivery to accelerate digital medtech innovation. Define and reuse mature and proven development processes to ensure compliance. Guarantee access control. Link regulatory requirements to development activities, and trace specifications down to source code. Gain the benefits of automatically documented versioning, and save baselines to record development milestones. Ensure complete transparency in release management as you file your products for CE approval.

Medical Risk Management

Ensure medical device safety by storing and controlling all risk-related information in a central system. Conduct risk identification and assessment early in the lifecycle. Use fully customizable artifacts to record, analyze, and manage risks, hazards, failure modes, corrective and preventive actions (CAPA), and all risk-relevant data. Rely on built-in FMEA support. Prioritize and link risks to work items and activities, define risk control activities, and follow them through execution and impact control. Monitor the efficiency of your risk mitigation activities, and visualize your overall risk level using Risk Matrix Diagrams. Easily access and export risk reports to demonstrate compliance with ISO 14971, IEC 60812, and other relevant standards.

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Medical Quality Assurance & Testing

Improve product quality and build trust in your medical devices using Codebeamer X. Derive testing artifacts from upstream work items such as requirements to maintain traceability. Manage your software and hardware testing activities and results all in one place. Parametrize test cases, execute testing manually or automatically (via Jenkins), and analyze test coverage effortlessly. Automate bug reporting to feed testing data back to development. Automate QA monitoring and export custom quality reports. Connect Codebeamer X to proven testing tools (see our list of integrations).

Document Lifecycle Management

Eliminate paper-based documents management with an automated digital solution. Upload or author, edit, and manage documents collaboratively. Rely on Codebeamer X‘s versioning capabilities to track changes to all your documents, and use advanced sign-off procedures. Use customizable document forms to gain clarity in document management. Define custom document workflows to automate processes, and take advantage of granular access control to ensure the safety of your documents. Use FDA-compliant, timestamped e-signatures to manage document approvals in a transparent and controlled way.

Quality Management System

Support your quality culture with a comprehensive digital Quality Management System. Maintain your quality documentation in the system, and share quality information internally via wikis. Manage approvals transparently and efficiently via the Review Hub for complete control over your processes. Handle eForms like Non-Conformance Reports, Corrective Actions Requests, risk items, and Corrective and Preventive Actions, all in one system. Support QA analytics, audits, and management reviews with custom-configurable QMS reports.

Easy DHF Maintenance

Provide your teams with a single source of truth for all quality & product data. Automate the documentation of lifecycle activities, and maintain your Design History File conveniently all in one place. Easily export lifecycle reports and your DHF, along with a full and automatically recorded audit trail. Granularly control permissions on the level of roles or individual users, and report on your access control measures. Make your quality strategy actionable by integrating quality documentation with development processes. Connect quality management and product delivery real-time. Provide single-pane-of-glass access to all quality management activities.

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Verification, Validation & Tool Qualification Support

Verify requirements easily in a collaborative manner. Trace and document reviews with fully compliant, timestamped e-signatures using the Review Hub. Validate your product through meticulous testing, and report on your activities in compliance with medical technology regulations. Reduce V&V costs by ensuring clarity, accuracy, and transparency along all your design, development, and documentation processes. Use automated Audit Trail Reports to accelerate regulatory audits. Obtain CE marking and other necessary certifications in any regulatory environment, and significantly reduce the effort costs of complying with IEC 82304-1, ISO 13485, ISO 14971, IEC 60812, IEC 62304, ISO 60601, EU MDR, FDA Title 21 CFR Parts 11 and 820, and more using our preconfigured templates.

Scale down the steep time and effort costs of software tool qualification for compliance. Our Validation Kit comes complete with all the assets you’ll need to validate your development tool.

Data Analytics Dashboards

Accurately monitor and report on all your medical device development processes. Custom-configure visual data analytics dashboards for clarity and precision in medtech innovation projects. Set up and automate the delivery of custom visual reports to help all roles track relevant KPIs. Gain actionable, real-time insights into the performance of your teams and projects.

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Preconfigured MedTech Development Templates

For developers of digital health tech products, our MedTech Templates provide instant access to baked-in best practices, compliant processes, and domain knowledge. Use these templates in Codebeamer X to save configuration time, cut project costs, reduce risks, and simplify compliance audits in digital health technology projects!

Functioning essentially as extensions to Codebeamer X, our templates come with predefined artifacts (trackers), regulatory compliance workflows, and MedTech domain knowledge. Artifacts contain preconfigured but flexibly adaptable fields and attributes, as well as traceable relations to other work items. All tracker types have underlying automation workflows that you can easily adapt to your environment and needs. Using these templates with Codebeamer X provides a good starting point to reduce the time and effort costs of configuration and compliance while reducing risks.

Pick the template that best suits your needs, and shorten your route to value and regulatory compliance with Codebeamer X! Empower your teams with customizable processes & tools to help them focus on innovation.

Our Templates for Medical Device Development

Medical-Software-Engineering-Template-Intland-Software Requirements, Risk, and Test Management for Medical Device Developers

Medical Software Engineering Template
Use this template to manage your medical device software design and engineering processes from requirements all the way through to validation. Take advantage of built-in medtech development knowledge to adopt best practices with minimal effort. Use the template to support compliance with EU MDR and US FDA regulations and applicable standards: IEC 82304-1, IEC 62304, ISO 14971, and FDA 21 CFR Parts 11 & 820.

Download Template Brochure

Medical-Audit-CAPA-Template-Intland-Software Requirements, Risk, and Test Management for Medical Device Developers

Medical Audit & CAPA Template
Use this template to ensure high product quality and accelerate regulatory audits. Build a robust Quality Management System, control quality documents, manage eForms and CAPA, and conduct Root Cause Analysis all in one place. Adhere to regulatory requirements, simplify compliance assessments, and tackle compliance audits for QMS regulations including ISO 13485:2016 and FDA Title 21 CFR Part 820. Rely on this template to maintain rigorous quality control across the entire development lifecycle, to manage deviations from established processes, and to report on your quality activities in order to simplify audits.

Download Template Brochure

Benefits of Codebeamer’s MedTech Development Templates

Faster configuration
Get up and running with codebeamer X for MedTech development in no time. Use templates to accelerate your products’ time to market.

Preconfigured yet flexibly adaptable
Our templates are ready to use out of the box. Artifacts and processes can be easily tailored to your organization’s individual needs.

Reduced compliance costs
Use templates for a streamlined compliance process with easier audit preparation and simplified regulatory submissions.

Reduced risks
Slash unnecessary risks by using preconfigured, compliant assets & workflows that meet regulatory requirements.

medtronic-customer-case-study-v2-593-840 Requirements, Risk, and Test Management for Medical Device Developers

Understand how Intland’s tool helped Medtronic Neuromodulation implement Agile in regulated development.

Download case study

fritz-stephan-customer-case-study-v2-593-840 Requirements, Risk, and Test Management for Medical Device Developers

Find out how Fritz Stephan uses Intland’s platform to enhance collaboration, transparency, traceability, and compliance.

Download case study

Requirements, Risk, and Test Management for Medical Device Developers

Deliver quality digital health products with Codebeamer X

Benefits of Codebeamer X for Developers of Digital Health Products

Integrated product delivery

Full risk management & audit support

Agility in regulated development

Intland’s Templates for Health Tech Development

Features for Medical Device Development

Medical Device Requirements Management

Embedded Software Development and Release Management

Medical Risk Management

Medical Quality Assurance & Testing

Document Lifecycle Management

Quality Management System

Easy DHF Maintenance

Verification, Validation & Tool Qualification Support

Data Analytics Dashboards

Find out what users think

Preconfigured MedTech Development Templates

Our Templates for Medical Device Development

Benefits of Codebeamer’s MedTech Development Templates

Understand how Intland’s tool helped Medtronic Neuromodulation implement Agile in regulated development.

Find out how Fritz Stephan uses Intland’s platform to enhance collaboration, transparency, traceability, and compliance.