Checklist for Vetting a Medical Molding Supplier
 
 
Quality & Compliance
 

• ☐ Verify active ISO 13485:2016 certification.

• ☐ Confirm cleanroom classification (e.g., ISO 7, ISO 8) and ISO 14644 certification.

• ☐ Schedule and conduct a full facility audit.

• ☐ Review the supplier's Quality Manual.

• ☐ Confirm process for full lot traceability and maintenance of Device History Records (DHRs).

• ☐ Review the Corrective and Preventive Action (CAPA) process.

• ☐ Verify their process validation protocol (IQ/OQ/PQ).

 
Technical Capabilities & Manufacturing
 

• ☐ Confirm direct experience with the specific medical-grade resins required for your project.

• ☐ Assess molding machine capabilities (all-electric presses for precision, tonnage range).

• ☐ Review mold design, fabrication, and maintenance processes.

• ☐ Clarify the mold ownership policy.

• ☐ Evaluate the range of secondary operations offered (assembly, pad printing, sonic welding, packaging, etc.).

• ☐ Inquire about sterilization management capabilities.

• ☐ Assess the level of automation and robotics used in manufacturing and inspection.

• ☐ Confirm they provide Design for Manufacturability (DFM) analysis and support.

 
Project Management & Support
 

• ☐ Confirm a dedicated Project Manager or single point of contact will be assigned.

• ☐ Review their New Product Introduction (NPI) process from start to finish.

• ☐ Obtain estimated lead times for both tooling and production parts.

• ☐ Request and contact customer references, preferably from other medical device companies.

• ☐ Understand their process for managing engineering change orders.

 
Business & Supply Chain
 

• ☐ Evaluate their supply chain management process and risk mitigation strategies for raw materials.

• ☐ Confirm they have the production capacity for your current and future volume forecasts.

• ☐ Assess the company's overall financial stability.

• ☐ Inquire about their disaster recovery and business continuity plans.