ALM for Medical Device Development
Medical Device development teams are faced with increased software complexity today when developing high quality devices. Software quality is a key differentiator for medical device manufacturers. Their quality regulations include traceability on requirements, methods, processes and tests used for developing and servicing their medical devices. More often than not full traceability is required to comply with development audits. In traditional development systems providing traceability means enormous costly manual work to find information in isolated issue trackers, shared folders, emails, version control repositories and on all change history.
codeBeamer’s security and process workflow features are designed to comply with regulations and standards defined by government agencies and the production industry. This includes codes of federal regulations (CFR’s) issued by the FDA, ISO and DIN industry standards. CodeBeamer supports electronic records and electronic signatures as described in CFR 21 part 11 and quality assurance features according to CFR 21 part 820.
codeBeamer is a 100% web based solution that provides integrated document management, wiki and a wide range of collaboration features. Working progress and important project information is available in real-time to all project members.