Agatha for Medtech

Streamlining Regulatory Submissions for Medical Devices

Bringing a medical device to market requires extensive documentation and strict adherence to regulatory frameworks such as FDA 510(k), PMA, and EU MDR. Agatha provides a structured document management system that centralizes submission documents, automates approval workflows, and ensures compliance with regulatory requirements, reducing the complexity of the approval process.

Managing Clinical Investigations with Ease

Medical device clinical trials differ from pharmaceutical trials, requiring specific documentation, post-market surveillance, and real-world data collection. Agatha’s eTMF solution supports efficient clinical trial document management, ensuring compliance with ISO 14155 and global regulatory standards while improving collaboration with investigators and regulatory bodies.

Ensuring Compliance with ISO 13485 and QMS Requirements

Compliance with ISO 13485 and other quality management standards is critical for medical device companies. Agatha simplifies quality management by providing automated workflows for SOPs, CAPAs, audits, and training records, ensuring regulatory compliance and reducing the risk of non-conformities.

Centralizing Document Control for Design History and Technical Files

Managing design history files (DHF), device master records (DMR), and technical documentation efficiently is crucial for medical device manufacturers. Agatha centralizes all essential documents, providing version control, audit trails, and secure access to ensure compliance with design control requirements.

Enhancing Post-Market Surveillance and Complaint Handling

Post-market surveillance and complaint management are essential for maintaining device safety and compliance. Agatha helps manufacturers track, manage, and analyze post-market data, ensuring timely reporting and compliance with vigilance reporting requirements.

Supporting Global Operations with Multilingual Document Management

Medical device companies operate in international markets, requiring multilingual document management and global regulatory compliance. Agatha enables seamless collaboration across different geographies by supporting multilingual workflows, ensuring consistency and efficiency in regulatory and clinical operations.