A full-process CDMO for medical devices
More than contract manufacturing — free end-to-end registration consulting. Supporting every medical device project from idea to compliant launch and stable production.
Company Profile
YISHIDA MST is a full-process CDMO dedicated to the medical device field, covering Class I, II and III devices.
The company has established design development, cleanroom production, quality compliance and registration submission capabilities, providing medical device start-ups, R&D teams and brand owners with an integrated route from prototype to commercial launch.
We depart from the traditional single-purpose manufacturing model by delivering R&D, validation, production, compliance and registration as one closed loop, reducing development cost and submission risk while eliminating the handover gaps that arise when several suppliers are involved.
Four capability systems
| System | Coverage |
|---|---|
| Design & development | Design inputs and outputs, validation evidence, risk management — from prototype to a manufacturable product definition |
| Cleanroom production | Cleanroom manufacturing, in-process parameter control, batch records and release management |
| Quality & compliance | Quality manual and procedures, DHF / DMR / production records, inspection preparation and continuous improvement |
| Registration capability | Classification, pathway planning, dossier writing and review, deficiency response, inspection coaching |
Our Advantages
01 A genuinely closed loop, no multi-party coordination
R&D, validation, pilot, volume production and registration compliance delivered as one service, reducing document gaps, process disconnects and diffused responsibility.
02 Registration consulting free of charge
Regulatory consulting, project coaching, regulatory Q&A, dossier review and risk forecasting — commonly charged separately in this industry — are provided at no extra cost. The free scope and its boundaries are stated in writing when the cooperation is confirmed.
03 Mature compliance system, fewer deficiencies
Documents structured along ISO 13485 principles with standardised DHF / DMR / production records, aligned with the logic of regulatory inspections: traceable data and standardised documentation.
04 Stable processes and real production capability
Addressing the industry's common problems — a good-looking prototype that fails in production, unstable batches, low yield — process lock-down is completed during validation so the project transitions smoothly to commercial scale.
05 A dedicated project owner and transparent progress
A dedicated project owner plus technical engineer and quality compliance staff follow the project throughout, with clear milestones, transparent progress and early risk warning.
Product Categories Covered
Class I, II and III medical devices, including innovative and improved devices, from low-value consumables to implantable high-value products.
| Category | Category |
|---|---|
| Consumables | Protective |
| Nursing | Rehabilitation |
| Active devices | Interventional |
| Implantable high-value consumables | Testing |
How We Practise
Medical devices are a heavily regulated field, and professionalism shows in the accuracy of what is said. These are our public commitments to clients.
- We do not promise certification dates. Review duration depends on device class, testing queues and documentation completeness. We provide schedule planning and milestone management, not time guarantees.
- We do not promise approval. Registration decisions are made by the regulatory authority. Our responsibility is to make documentation and systems standardised and traceable, reducing deficiencies and rework.
- We do not issue classification conclusions on behalf of the authority. Classification follows the Classification Catalogue and definition documents; products not covered by the catalogue go through the classification definition procedure.
- Credentials are open to verification. Registration certificates, manufacturing licences, laboratory accreditation and system certificates can all be verified publicly by number. We encourage independent verification and welcome site visits.
- Chargeable scope is stated in writing. Free scope and chargeable items are listed before signing, and third-party costs are invoiced as incurred.
Let's discuss your device
Start with a free project assessment — define the pathway before deciding the next step.