Your Integrated Quality & Regulatory Compliance Platform for Health Tech Innovation
Codebeamer combines software quality assurance with development support in medical device innovation. Manage QA, traceability, and regulatory compliance all in one ALM tool. Ensure successful FDA approvals & EU MDR audits.
Enable MedTech teams to go Agile while maintaining compliance. Cut product development & quality control costs. Reduce risks and streamline compliance with ISO 13485, EU MDR, FDA Title 21 CFR, ISO 14971, and more.