Full-process support for medical device companies, R&D teams and trading partners. Product definition, registration certificate, quality system and contract manufacturing planned on one project schedule, led by a single project owner from start to finish.
Dossier writing, quality system setup, registration pathway planning, classification, deficiency response and inspection readiness coaching — charged separately by most suppliers, included at no extra cost when you work with us.
The first conversation needs only five questions — a 20-minute screening. We define the classification, evidence pathway and timeline before quoting with clear boundaries.
Completing R&D is only the starting point. What really determines your time to market is whether classification, registration, quality system and validation connect into one line. These are the four issues we see most often during project assessment.
The same product under a different classification means completely different dossiers and timelines. Get the pathway wrong and everything is reworked later.
Without one coordinated schedule, serial waiting stretches the timeline and rework costs rise the further you go.
The dossier looks excellent, but records do not match actual production — problems surface during the on-site inspection.
Quotes are split across several suppliers, yet nobody takes overall responsibility, and mid-project price increases are common.
From "can this be done" to "can it be manufactured consistently" — every step led by the same project owner.
Classification, pathway planning, dossier writing and logical review, quality system setup, deficiency response, inspection coaching.
Learn more →Testing at accredited laboratories: performance, safety, EMC and biocompatibility, with formal test reports.
Learn more →Demonstrating that the sterilization method is safe and effective — EO, irradiation and other mainstream methods.
Learn more →Simulating vibration, drop, temperature and humidity to prove the packaging protects the device in distribution.
Learn more →Pilot and commercial production in a cleanroom, including process lock-down, in-process control, release and change management.
Learn more →Filing formalities for Class I devices. Filing is a formal review and results in a filing certificate, not a registration certificate.
Learn more →Applying for the manufacturing licence required for contract production, including site, personnel and system preparation.
Learn more →Consumables, protective, nursing, rehabilitation, active devices, interventional, implantable high-value consumables, IVD-adjacent testing.
Learn more →
Consumables · Protective · Nursing · Rehabilitation · Active devices · Interventional · Implantable high-value consumables · Testing — including innovative and improved medical devices.
Product definition, registration certificate, quality system and contract manufacturing on one project schedule — eight milestones, each with defined deliverables and an owner.
Answer five questions in 20 minutes to confirm classification and registration pathway.
What must be done, why, and by whom — written into a project list before quoting.
Design inputs and outputs established alongside validation evidence.
Performance, safety and stability validation, with process parameters fixed.
Test reports aligned with technical requirements to form a complete submission package.
Documentation, submission and deficiency communication accompanied throughout.
Rehearsal against review logic, closing findings before the on-site inspection.
Batch consistency, yield and release management, with ongoing compliance support.
Time required per milestone, deliverables and client inputs.
Open Process →20 minutes is enough for a project screening — define the pathway first, then decide the next step. The assessment is free of charge and requires no agreement.
