CertHub provides an AI-first platform for medical device compliance, streamlining eTechnical Documentation (eTD) and electronic Quality Management Systems (eQMS). The solution automates design control processes to accelerate certification under regulations like EU MDR and IVDR. This allows MedTech manufacturers to focus on innovation by reducing manual regulatory workload and ensuring audit-ready documentation.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device manufacturers face increasing complexity and costs associated with regulatory compliance, including the need for extensive documentation and adherence to evolving standards like MDR and FDA 510(k). These challenges can lead to delayed product launches, increased risk of errors, and significant resource burdens, hindering innovation and market competitiveness.
Solution
CertHub offers a unified, AI-powered platform designed to streamline regulatory processes and quality management for medical device companies. The platform provides a digital Quality Management System (QMS) and tools for technical documentation, enabling users to centralize product data, automate document creation, and ensure continuous compliance. By automating workflows, providing standardized templates, and offering real-time compliance monitoring, CertHub helps manufacturers reduce manual errors, accelerate time-to-market, and efficiently manage post-market surveillance. The system supports multiple regulatory frameworks, facilitating global market expansion with one-click submissions.
Target Audience
CertHub primarily targets medical device manufacturers, ranging from startups to SMEs, producing software and hardware products across risk classes I, IIa, IIb, and III, as well as quality management and regulatory affairs professionals.
Features
- Centralized data management for a single source of truth, eliminating inconsistencies and redundant data entry
- Smart editor to connect product data to templates, automating document generation
- Pre-built and customizable templates aligned with Notified Body expectations for efficient documentation
- Automated workflows for user management, task assignment, and simplified documentation
- AI assistant for comprehensive search across all data, including PDFs and scanned documents
- Version control for tracking product and process changes, ensuring audit readiness
- Automated approval processes with digital e-signatures for secure and compliant workflows
- Support for multiple regulatory frameworks, including MDR, FDA 510(k), Anvisa, and PMD Act
- Post-market surveillance tools for automated reporting and compliance management
- Integration of compliance checks into the engineering workflow