Challenge

Internal audits revealed raw material inconsistencies in a Class III resorbable implant which was commercial.
These quality discrepancies posed serious regulatory risks under both FDA and EU MDR frameworks. Left unresolved, the issue could jeopardize market continuity or result in product recalls in post-market.

‍

Chemva’s Solution

Chemva developed and implemented a risk-based supplier qualification framework, grounded in ISO 13485 and ISO 10993-1 principles.
This involved:

• Mapping out the entire raw material supply chain for quality gaps.
• Auditing current and potential suppliers to assess compliance, material certification robustness, and regulatory readiness.
• Evaluating key risk indicators, including batch variability, documentation completeness, and long-term supply resilience.

Chemva identified and vetted multiple vendors, ultimately recommending two top-tier suppliers with the capability to provide high-purity, traceable materials with minimal variability.

‍

Impact Delivered

The sponsor conducted further material validation testing with both recommended suppliers, ultimately qualifying both as approved sources. Chemva’s strategic framework established a reliable and redundant supplier network, significantly reducing future sourcing risk and ensuring ongoing material consistency, a critical factor for Class III implant safety and compliance.