Medical Device Qualified Supplier Directory
Plas-Tech Engineering, Inc / Equinox Medical Company Profile
Qualifications: ISO 13485, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe
Plas-Tech Engineering Inc. has more than 30 years' experience in medical device molding, ISO 13485/FDA GMP–compliant product development, and manufacturing. The company is an expert in medical device manufacturing which utilizes in house mold manufacturing and cleanroom injection molding, ISO Class 6 medical assemblies, product/kit packaging and sterilization and light distribution. Plas-Tech's division, Equinox Medical, is well a well established manufacturer of pre-fillable syringes (PFS) made with glass alternative COP/COC, PC, cPET and PP resins. Plas-Tech is also highly proficient with insert molding, multishot, IML, thin-wall, and micromolding Other expertise includes FDA validation services and packaging/shipping validations to assure products arrive intact and maintain sterility.