Accelerate product innovation and delivery in automotive embedded software development

Define, manage, change, and trace requirements along the development lifecycle. Ensure efficient collaboration across stakeholders, optimize reuse, and integrate quality testing in product development.

Build safe and reliable products, and take the headache out of compliance with MedTech regulations. Integrate traceable risk management workflows and automate quality documentation to cut the costs of regulatory audits.

Define, plan, manage, automate, and track product testing with full traceability to requirements. Track test coverage, monitor tests-requirements consistency, and automate quality documentation & reporting.

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.

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.

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.

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).

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.

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.

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.

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.

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.