Quality & Manufacturing
We draw the fixtures and the inspection steps at the same time as the product. Do it the other way round and you end up trying to add quality by inspection, which does not work.
Certification and conformity
| Quality management | ISO 13485:2016 at every plant, plus ISO 9001:2015 |
|---|---|
| Environment | ISO 14001:2015 |
| Japan | Class I marketing authorisation and device manufacturing licence |
| Europe | EU MDR (2017/745) conformity and CE marking |
| United States | FDA establishment registration, with 510(k) clearances on selected items |
| Production equipment | GMP compliant, supplied with a full IQ/OQ/PQ document set |
How production runs
01
Design and process design
The product drawing and the inspection plan are fixed together.
02
Incoming inspection
Every lot from an approved supplier is inspected on arrival.
03
Assembly and cleanroom
Sterile products are assembled in an ISO Class 7 environment.
04
Final test and release
The Quality Control Director decides release independently.
Production sites
Yao No.1 and No.2 Plants
Sterilization, surgical and aseptic production equipment. 2,400 m² of cleanroom.
Sagamihara Plant
From board assembly through to finished monitors and pumps.
Hai Phong Plant
Moulding, assembly and EO sterilization of single-use products.
Service and parts
- Repair parts are supplied for ten years after production ends.
- In Japan we work to a 48-hour on-site response.
- Installation calibration records and annual inspection records are held electronically.