Tessy can meet even the most rigorous demands for quality – such as those imposed by the FDA and by medical device companies.
Cutting-edge Quality Control Machinery and Software.
FDA-Regulated Facilities that Meet GMP Requirements
Tessy is in total compliance with the rigorous standards required to remain an FDA-regulated facility.
ISO 13485 Certified and UL Approved
Embracing global standards of excellence, Tessy meets - and exceeds - operating standards and customer satisfaction requirements outlined by ISO and UL.
Ultimate Traceability
Tessy is experienced in providing 100% accountability in every process. Through serialization and lot control, Tessy ensures each product can be traced back to its originating source, whether that source is a component, material or machine.
Gage R&R for Statistical Quality Control (Repeatability and Reproducibility)
SIM-Certified and Approved (Scientific Injection Molding)
Six Sigma Quality
DOEs
Cleanroom Molding (IS0 7 and ISO 8)
Optical Inspections for Zero-Defect