pacific edge solutions DEVICE CO., LTD.

Design and Development Capabilities

Pacific Edge Solutions engineering team has 86 engineers, senior engineers have worked within medical device more than 15 years.

Pacific Edge Solutions partners with institutes, universities and hospitals to develop new material formula, new design to meet customer and clinical demands.

Pacific Edge Solutions has 116 patents on material formula, process technology, molding and product design.

Molding workshop can support mold and tooling design, fabrication and maintenance.

Testing and Validation Capabilities

Full assay testing laboratory:

Physical testing includes dimensions validation method through image coordinate, mechanical testing, particle pollution level testing, Luer functional testing, transportation simulation, tightness testing, simulated aging, etc.

Chemical testing covers component testing, ethylene oxide residue testing, etc.

Biological testing capabilities include initial contamination bacteria testing, sterility testing , etc.

RA Capabilities

Regulatory team has 6 experienced members, can provide services of CE,FDA,NMPA, etc.

Manufacturing Capabilities

Plastic molding injection

Silicone Vulcanization

Rubber Vulcanization

Silicone Extrusion

Precision Extrusion

Catheter Braiding

Balloon Forming

Catheter Welding

Formula mixing

Punching

Printing

Assembly

ETO Sterilization etc.

Packaging and Sterilization Capabilities

Pacific Edge Solutions can provide packaging and sterilization services to their customers.

Our equipment includes automatic packaging lines and ETO sterilization chambers.