Medical software development is essential to the healthcare industry and must meet stringent regulatory requirements. That’s where Codebeamer’s Medical Software Engineering Template comes in. The template revolutionises medical software development by offering a range of benefits and capabilities that streamline the development process while ensuring compliance, including integrated quality control.

 

What are the benefits of Codebeamer’s Medical Software Engineering Template? 

 

1. A shorter route to value – Use this template out of the box to implement a fully compliant development project. Reduce effort, costs, and time to market.
2. Medical compliance – Use an all-in-one hub to manage all your technical content for CE marking & US FDA market access reviews. Rely on compliance support for EU MDR/IVDR (Class I to III), IEC 62304, ISO14971, ISO 13485, FDA Title 21 CFR Part 11 & Part 820, IEC 82304-1.
3. Integrated quality management – Automate process control in medical software development to avoid deviations. Connect quality control and audit management using the Medical Audit & CAPA Template.
4. Fully configurable – Adapt preconfigured artifacts and processes to your needs. Configure the template for a tailor-made solution for development support and compliance. 

 

One of the key benefits of this template is its configurability. It provides preconfigured artifacts and processes that can be adapted to meet specific needs, resulting in a tailor-made solution that supports development and compliance. This template also offers a shorter route to value, as it can be used out-of-the-box to implement a fully compliant development project, reducing effort, costs, and time to market.

 

The template’s integrated quality control mechanism is critical in ensuring the quality of the medical software. Quality control is automated in the development process to avoid deviations, and it connects to the Medical Audit & CAPA Template to make it easier to manage and track risks. This ensures that the end product meets the required standards and regulations.

 

Medical compliance is of utmost importance in this field, and the template provides an all-in-one hub to manage all technical content required for CE marking and US FDA market access reviews. It also supports EU MDR/IVDR (Class I to III), IEC 62304, ISO14971, ISO 13485, FDA Title 21 CFR Part 11 & Part 820, IEC 82304-1, ensuring that all regulatory requirements are met.

 

The template provides comprehensive support from development to release, offering end-to-end traceability and predefined queries to answer typical traceability-related questions. It supports the entire medical software development lifecycle, including lifecycle product risk management, documentation management, technical file & design history file, design control, verification & validation, vigilance & post-market surveillance, SOUP and legacy software management, and more.

 

In conclusion, Codebeamer’s Medical Software Engineering Template provides a comprehensive solution for medical software development, ensuring compliance while streamlining the development process through integrated quality control. It’s a must-have tool for organisations in the medical technology sector.

 

CAD-IT Australia’s vision is to provide digital solutions for real-world business challenges. Using the latest cutting-edge technologies and extensive expertise, we aim to help organisations succeed with Codebeamer’s Medical Software Engineering Template. Contact our team today to learn more, or download the Codebeamer Medical Software Engineering Template below.