In today’s global medical device landscape, material innovation and multi-market regulatory compliance must move in lockstep.

Between the stringent requirements of the EU MDR, FDA 21 CFR Part 820, and Health Canada, the challenge is no longer just managing materials, it is managing the data that proves their safety. From the traceability of implantable polymers to the complexity of biocompatibility documentation, digital technical data management has become a critical strategic asset.

Join our experts for a specialized session on our materials solution for medical devices, where we will explore:

• Unified Material Intelligence: How to centralize, compare, and share medical-grade material data in a “Single Source of Truth” that meets ISO 13485, FDA, and EU regulatory standards.
• Accelerated Global Filings: Streamline the preparation of Technical Documentation (EU), 510(k)/PMA (US), and Medical Device License (Canada) applications using automated data exports.
• Compliance by Design: How to integrate Design History Files (DHF) and biocompatibility data (ISO 10993) directly into your R&D workflow to avoid late-stage regulatory roadblocks.
• Cross-Border Traceability: Maintain a robust digital thread for polymers, alloys, and metals, ensuring you are “Audit-Ready” for notified bodies and national competent authorities alike.
• Strategic Supply Chain Management: Secure your global partnerships through a unified, connected supplier reference database that tracks compliance across your entire vendor base.