Our Process
A structured, six-phase development process grounded in design controls, risk rigor, and verification discipline. Our process is designed for real-world product development: technical de-risking early, verification evidence that maps to requirements, validation activities that support intended use, and a clean path into design transfer—aligned with FDA expectations and ISO 13485 practices.
Phase 1:
Feasibility & Planning
Define the requirements, intended use, and regulatory pathway (e.g. 510(k) or De Novo). Build the development plan, early risk posture, and requirements so scope, cost, and timelines stay predictable. Technical de-risking of concept(s) through focused alpha prototyping and early feasibility testing.
1
Phase 2:
Development
Turn requirements into a buildable design: architecture, CAD, prototyping, supplier strategy, and design outputs—while keeping traceability, risk controls, and documentation moving in parallel.
2
Phase 3:
Design Verification
Prove the design meets requirements with right-sized verification planning, test method development (as needed), and execution that produces clean, reviewable evidence—not just raw data. When appropriate, we also run early manufacturing pilot builds of test articles to support verification testing and uncover build/assembly risks before design transfer.
3
Phase 4:
Design Validation
Confirm the device works for users and the intended use case—usability/human factors and validation activities that hold up to scrutiny. We build the submission package throughout development, and typically submit to FDA toward the end of this phase (e.g., 510(k) or De Novo).
4
Phase 5:
Design Transfer
Convert the design into a controlled, repeatable manufacturing process: DMR/DHR readiness, process validation planning, incoming inspection, fixtures/tooling, and quality controls.
5
Phase 6:
Commercialization
Launch with execution discipline—final documentation, readiness reviews, manufacturing scale-up, and post-launch support to keep quality, cost, and delivery on track.
6
.svg)
.svg)
