Medical Devices Software – To Develop High Quality Devices

Medical Device development teams are facing with increased software complexity today to develop high quality devices. Their quality regulation includes traceability on requirements, methods, processes and tests used for developing and servicing their medical devices.During the delivery for traceability information required to comply audits. What happens traditional development systems? Enormous costly manual work begins to find information in isolated issue trackers, shared folders, emails, version control repositories and on all change history.

CodeBeamer platform helps medical device development teams to manage their processes from requirements to release. With centralized management of processes, users and projects, codeBeamer increases productivity, provides full traceability, gains visibility and dramatically reduces audit costs. Traceability and compliance information are automatically derived from the system for QA audits.

codeBeamer Solution for Medical Device Engineering

CodeBeamer fuels your team with facilitating collaboration on requirement specification. The tightly integrated wiki, document manager and issue tracker allow domain experts, requirement engineers, software developers, QA engineers and project stakeholders to capture, draft and define requirements, as well as their relationships with releases or tests.

• Collaborative Requirement Composition codeBeamer keeps your whole team involved in the process, including domain experts, engineers, customers, and stakeholders. It also helps them to understand the impact of changes. For efficient team work, codeBeamer offers a rich set of enterprise collaboration features, like integrated wiki- and document workflows, realtime activity streams, notifications, alerts, voting and full text search on all types of documents and artifacts.
• Implement, Document and re-use Processes Requirement trackers, review- and change management workflows can be customized to support your own organization specific processes. Both standard and custom process templates can then be easily reused in new projects.
• Link Requirements and Derive Actionable Work Items Clearly specifying your requirements is only the beginning of the work. codeBeamer will also help you to connect actual feature requests, change requests, tasks, defects and test cases to the requirements captured. Both the requirements and the actionable work items can be organized into hierarchies in order to better model the problem domain.
• Baselines Using baselines you can make lightweight snapshots of the whole specification, including wiki pages, documents, images, attachments and all other types of artifacts. This is the primary means for versioning the states of the rapidly changing requirement specification, along its evolution. The baselines are optimal for comparing two states of documentation, computing deviation between two states, for audit purposes, and for certification for an approval.
• Document Management with ISO 9001:2008 complianceCodeBeamer satisfies requirements of the ISO 9001:2008 standard, from content management point of view. codeBeamer enables accurate versioning of content, periodic document reviews, approval workflows, complete trace of changes, full text searchibility and content consistency via baselining, among others.
• End-to-End Traceability Due to codeBeamer’s flexible data model and artifact linking capability, the whole lifecycle of your product can be precisely tracked from requirement capture phase, through development and test, until release.
• Fine-grained Access Control codeBeamer provides enterprise grade security, based on user accounts, roles, groups and a granular system of permissions. It also integrates with your LDAP directories.
• 100% Web-based, Scalable, Extendable codeBeamer is 100% web-based. It easily scales to hundreds of users, making it possible to involve not your organization only, but to provide controlled access for your partners, vendors and customers, as well. Using its API (Application Programming Interface), codeBeamer can be easily extended, customized and integrated with your own applications, third party tools and services.
• Low Cost of Ownership codeBeamer is quick to adapt. Administrative and IT infrastructure costs are minimal.