Eight milestones, each with defined deliverables and an owner
R&D, validation, production and compliance delivered as one closed loop. The first assessment step is free — define the pathway first, then decide the next step.
Eight cooperation milestones
From kick-off to stable commercial production, each milestone states what is done, what is delivered and what is needed from you.
Kick-off & free assessment
Five questions: what the product is, its intended use, the current stage, existing documentation and target launch date. We then provide classification direction, pathway advice and an initial timeline.
Deliverable: assessment conclusion and pathway advice
Scope & cooperation confirmation
What must be done, why and by whom is written into a project list with chargeable items itemised. Work begins only after mutual agreement.
Deliverable: project plan and quotation list
Design & prototype development
Design inputs, outputs and validation evidence are built together so that the registration dossier and the actual product stay consistent.
Deliverable: design history file and prototype
Validation & process lock-down
Performance, safety and stability validation, while process parameters are fixed into repeatable work standards — solving the "good prototype, unstable production" problem.
Deliverable: validation reports and process documents
Type testing & dossier support
Testing at accredited laboratories, with reports aligned item by item to technical requirements and research data to form a complete submission package.
Deliverable: test reports and submission package
Free registration consulting & filing support
Documentation, submission and communication with the reviewer are accompanied throughout. Deficiency responses and remediation guidance carry no extra charge.
Deliverable: accepted submission and deficiency responses
Inspection readiness & remediation
Rehearsal against review logic, aligning the document system with shop-floor records and closing findings before the on-site inspection.
Deliverable: readiness preparation and remediation records
Stable commercial production
Volume production with attention to batch consistency, yield and release management, plus change management and ongoing compliance support.
Deliverable: production batches and batch records
Indicative project timeline
Market reference ranges; actual duration depends on device class, test items and completeness of documentation. We do not promise certification dates, but we do state each milestone's time requirement up front.
Preparation & filing
Product definition, classification and documentation review.
Registration & validation
Testing, clinical evaluation or equivalence, system operation.
Review & inspection
Submission, deficiency response, on-site inspection, certification.
The first conversation needs only five questions
20 minutes is enough to screen a project. No documents to prepare, no agreement to sign.
What is the product, and what is its intended use?
Intended use drives classification, and classification drives everything else.
Where are you today?
Idea only, prototype available, testing underway, or already submitted.
Do you have your own facility or manufacturing licence?
Determines whether contract manufacturing and licensing support are needed.
Do you already hold a certificate, and which route do you plan?
Existing data, patents or equivalence evidence can often be reused, directly affecting timeline and cost.
When do you plan to start selling?
Working backwards from your date tells us which steps must run in parallel.