ePAPER
Codebeamer Medical Software Engineering Template
Streamline the development of compliant medical software with the Codebeamer Medical Software Engineering Template. Download the ePaper to explore its powerful features and benefits.
Optimize Compliance with the Medical Software Engineering Template
Simplify regulatory compliance and accelerate your medical software development process with the Codebeamer Medical Software Engineering Template. Designed for modern healthcare needs, this template supports seamless development while ensuring adherence to EU MDR, FDA and other global standards.
Why Use the Medical Software Engineering Template?
1. Streamlined Compliance: Preconfigured for EU and US regulatory requirements, including IEC 62304, ISO 14971 and FDA 21 CFR Part 11.
2. Customizable Solutions: Tailor artifacts and workflows to fit your unique development needs.
3. Faster Time-to-Market: Reduce effort and costs with ready-to-use templates.
4. Integrated Quality Management: Automate quality and audit processes to prevent deviations.
Key Capabilities:
1. Requirements Engineering: Manage interconnected requirements with full traceability.
2. Risk Management: Track and control risks throughout the product lifecycle.
3. Documentation Management: Easily generate compliant technical and design history files.
4. Verification & Validation: Ensure traceable and reportable product testing.
5. Post-Market Surveillance: Simplify vigilance and market recall activities.
Complete Your Medical Software Development with Confidence
The Codebeamer Medical Software Engineering Template streamlines your development process, ensuring regulatory compliance, effective risk management and quality assurance. With this solution, you can accelerate time-to-market while adhering to global standards.
Ready to enhance your medical software development? Download ePaper to learn more.
