One partner. Clear milestones. Accountable from first call to scaled production.
We operate as an extension of your team — not a vendor fulfilling a purchase order. Every engagement is governed by defined milestones, named accountability, and direct access to the engineers and regulatory specialists doing the work. No account managers between you and the people solving your problems.
Four structured phases — from your first conversation to a device in market.
We review your concept, clinical intent, target markets, and regulatory constraints. We assess technical complexity, identify risk flags, and outline a credible program path — before you commit any development budget.
A Feasibility Assessment Report with a clear go/no-go recommendation, program outline, and risk flags — before any commitment.
We scope the full engagement: workstreams, milestones, team structure, regulatory approach, and success criteria. A Program Definition Document is signed before engineering begins. No ambiguity on either side.
Fixed scope. Milestone-based commercials. Named team leads. A governance cadence agreed in writing.
Engineering, regulatory, quality, and manufacturing workstreams run in parallel under a single Program Manager. Weekly progress reporting. Monthly governance reviews with your leadership. Issues escalated — not hidden.
A single point of accountability for your entire program. Transparent milestone tracking and rapid issue resolution.
Manufacturing ramp-up, supply chain stabilisation, and — where required — technology transfer to your team or a designated manufacturing partner. We stay involved until you are stable.
A device in market, a qualified supply chain, full documentation ownership, and a sustaining engineering path forward.
Choose the model that fits your program — from full end-to-end partnership to a focused single workstream.
Concept to commercial manufacturing. One partner, full accountability across all workstreams — engineering, regulatory, quality, and production.
A specific workstream only: regulatory strategy, QMS implementation, manufacturing, SaMD development, or sustaining engineering.
Long-term dedicated engineering team in India, operating under your governance and IP framework. Built to scale with your program.
Senior regulatory and quality advisory on a monthly basis — for ongoing programs that need expert input without a full team engagement.
Tell us where your program is today — we'll tell you exactly how we can help and what the first step looks like.
Schedule a Discovery Call