Design, Development, and Manufacturing of Medical Device
One of our aims is to strengthen domestic development and manufacturing of medical device that are innovative and safe, with our tradition of “Monodukuri” backed by strong technological capability that Japan has.
When developing and manufacturing a new product, we support a whole process throughout, from specification/prototype to actual manufacturing. It is also possible that we participate partly in the process. Making prototype, finding manufacturing subcontractors that are properly approved / certified for medical device – consulting for such clients’ needs is available here.
Production Process
Developmental Stage
-
Specification / Design
We start from hearing from clients’ requests to decide specification of a product.
-
Prototype
According to the specification, a prototype can be made at our laboratory. At J-sol Medical, it has equipped a 100,000 class (ISO5) cleanroom. Outsourcing of making a prototype with our partner companies is also an alternative.
-
Verification
We conduct efficacy measurement for medical device. When in outsourcing a trial, we can support liaisons with various test institutions.
Manufacturing Stage
-
Production
Products are being made according to a manufacturing system based on QMS ordinance at our manufacturing site.
-
Quality Inspection
After manufacturing, quality inspection is carefully carried out, based on each product’s requirements.
Our Manufacturing Site
Clean Room
-
As for manufacturing facility especially for medical device, we are equipped with cleanroom; though medical devices are particularly sensitive to particles, this made us possible to manufacture inspect them in-house. Well-trained staff will support to improve products’ quality.
Cleanroom Specification
Class ISO8 100,000 (0.5μm) Area 52m2 Capacity 123m3 Filter HEPA filter Ventilation 29 times/h
Laser Welder
-
Laser Welder Specification
Type Nd : YAG Laser
Wavelength: 1064nmProtection Class 4
Max average output : 50wPulse Peak Power 5KW
Max Output Energy : 40JPulse Width 0.5 -20 ms
Beam divergence angle : 100πrad
Accomplishment
Transesophageal Probe
a type of catheter that enables continuous measurement of temperatures in esophagus
Temperature Measurement Apparatus
a digital display device for catheter that continuously measures temperatures in esophagus
