Our product development process provides a systematic, phase-gate approach to new product development and commercialization. It’s tightly aligned with our Quality Management systems. We proactively guide our customers through the key design engineering, quality, manufacturing, and regulatory deliverables for each stage of the process.
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Concept
Transform an idea, thought, or sketch into a design with a working and functioning prototype that simulates the intended device and its intended use in the market.
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Feasibility
Establish ''design freeze'' that presents a working engineering-level sample with initial evidence supporting the design feasibility.
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DFM
Ensure using an iterative process that the product is manufacturable and meets quality and cost targets.
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Design qualification
Verify and validate that the device meets design requirements and is safe and effective.
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Clinical validation
Obtain clinical feedback to ensure that the device specifications align with user needs and intended use.
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Regulatory submission/approval
Obtain regulatory approval. Our in-house regulatory affairs specialists can help you prepare your regulatory submissions for the FDA and other notified bodies as required.
