New Product Introduction
Flexan New Product Introduction
Relying on custom manufacturers for the components you need to produce medical devices can be a source of risk to your supply chain. At Flexan, we deliver the predictability manufacturers demand by strictly adhering to both customer specifications and working within the requirements of the FDA and other relevant regulatory bodies, while also meeting your critical project timelines.
Our 7-Phase Approach
Flexan New Product Introduction processes cover a range of items, including molded and extruded products, components and finished medical devices, and even the equipment and processes employed by Flexan. For the benefit of our customers, we adhere to a strict seven-phase approach that eliminates inefficiencies, errors and missteps while maximizing predictability.
Phase I: Concept
We begin by determining overall manufacturing feasibility of your new product.
Phase II: Quotation
Once feasibility is determined, we develop a customized quote for the manufacturing services of your product, including all custom tooling, engineering and validation requirements.
Phase III: Contract Review
In this phase we oversee formal acceptance of the purchase order, reviewing all contract terms and conditions to ensure we are aligned with your expectations.
Phase IV: Manufacturing Transfer
We receive all relevant design details and documents (including prints, specifications, regulatory filing requirements, audits, etc.) to ensure we can comply with your complete product design requirements and expectations.
Phase V: Process Design/Verification
This phase describes the efforts of our cross-functional teams to design the tools, equipment and processes to manufacture to your specifications.
Phase VI: Process Validation
This critical step includes a robust IQ/OQ/PQ methodology to ensure that our production processes can achieve your process capability requirements. Validation includes all manufacturing equipment and/or manufacturing processes as well as for other elements, including facilities, software and special processes such as sterilization.
Phase VII: Production
In this final stage all manufacturing processes are confirmed and transferred from development status to locked production status, ensuring stability and consistency in all future production orders.
Change Control
Once a product is released, we utilize a tightly administered change control procedure to manage any manufacturing alterations, including specification updates, product design, product packaging/labeling and/or process design.