Coauthor is a compliance software solution that automates the generation of IEC 62304 and ISO 14971 compliant documentation for software as a medical device (SaMD), integrating directly with development tools to capture evidence and enforce compliance in real-time. By streamlining compliance processes, Coauthor reduces the need for regulatory consultants and can lower development costs by up to 30%.
Funding
Funding not disclosed
Founders
Product
Problem
Developing software as a medical device (SaMD) requires strict adherence to IEC 62304 and ISO 14971 standards, creating a heavy documentation burden for development teams. Maintaining compliance often involves expensive regulatory consultants and manual processes, slowing down development cycles.
Solution
Coauthor is a compliance automation platform that integrates with software development tools to streamline documentation for SaMD. The platform allows users to define their software development process and automatically generates IEC 62304 and ISO 14971 compliant documentation. By continuously monitoring development activities, Coauthor highlights compliance issues in real-time and enforces compliance checks, ensuring that documentation stays up-to-date and reducing the risk of non-compliance.
Target Audience
Coauthor is designed for software development teams in the MedTech industry building SaMD products who need to streamline compliance with IEC 62304 and ISO 14971.
Features
- Automatic generation of IEC 62304, ISO 14971, and ISO 13485 compliant documentation
- Continuous monitoring of software development tools for compliance issues
- Pull request checks to enforce evidence or required documents for the technical file
- Traceability matrix generation between requirements, risks, defects, and verification tests
- Smart SOUP (Software of Unknown Provenance) identification and analysis
- Automatic evidence capture from code reviews and test results
- Support for Cucumber, including screenshots and log files, for integration and system testing
- Software Bill of Materials (SBOM) recording in CycloneDX format