Medical software engineering
template

Medical Software Engineering Template with Codebeamer 

The Medical Software Engineering Template for Codebeamer streamlines the adoption of best practices for medical device software engineering with minimal effort. It significantly reduces the time and resources required to develop high-quality digital health products that align with EU MDR, U.S. FDA regulations, and other international standards. Utilize this template to effectively manage medical device software design and engineering processes from requirements to validation and regulatory audits.

This template seamlessly integrates with Codebeamer, providing immediate access to best practices, regulatory-compliant processes, and domain knowledge specific to health technology.

Compliance support for EU MDR and US FDA
regulations and applicable standards: IEC 82304-1,
IEC 62304, ISO 14971, and FDA T21 CFR Part 11 & 820

It comes with predefined assets and workflows tailored for medical device development and compliance. By leveraging this template, you’ll save valuable time and effort in configuring Codebeamer while ensuring regulatory compliance and mitigating risks associated with complex health technology products.