Design Transfer
From product development to volume production
The goal of the design transfer is to transfer all development-relevant information completely, clearly, and traceably into volume production.
Design transfer provides a controlled link between development and volume production. It transfers all relevant information in a complete, unambiguous, and traceable manner. Safe, consistent and audit-ready production relies on clearly defined and documented requirements, specifications, bills of materials, test procedures and manufacturing processes.
Iftest Medical Manufacturing (IMM) helps MedTech companies systematically industrialize their products. We review and consolidate the technical documentation, define product-specific manufacturing and test processes, and prepare the product for manufacturing that complies with FDA regulatory requirements with full traceability and documented procedures.
The result is a controlled and documented move from product development to volume production. The result is a scalable, audit-ready and compliant manufacturing process for Finished Devices for the US market.
We help turn developed medical devices into Finished Devices ready for controlled, repeatable volume production in the US market.
The design transfer process ensures that development data, specifications and quality requirements are complete, traceable and ready for volume production. This makes production more consistent, reduces risk and helps maintain regulatory compliance.
Key documents include technical specifications, bills of materials, manufacturing documentation, test procedures, risk assessments, and development and quality documentation. IMM helps customers review, consolidate and complete the documentation they need.
IMM reviews existing product and development documentation, defines product-specific manufacturing and test processes, and prepares products for scalable, audit-ready volume production that meets FDA regulatory requirements. Working closely with development teams, we identify risks early and keep industrialization on track.
Contact
We are here for you and happy to answer your questions.
Massimiliano D’Amore
Head of Operations
verkauf@iftest-medical.ch
+41 56 552 55 72
