ISO 13485 Medical Packaging & Assembly

Virtually every project is unique at Quality Tech Services, which is why we develop customer-specific assembly procedures to meet individual customer specifications. Documented procedures and guidelines are executed by highly trained technicians on validated equipment. Our skilled technicians prepare assemblies with meticulous accuracy upheld by redundant verifications under the control of QTS’s Quality Management System.

 That means for every new project, packaging and assembly personnel participate in technical training before beginning assembly. In-depth training practices ensure complete comprehension of every project, and effectively communicate proper handling procedures for safe, accurate procedures.

Numerous projects require specialized equipment, and QTS has the capabilities to utilize customer-supplied equipment as well as source equipment directly for use in our facility.  In our Class 7 cleanrooms we adhere to industry standards that reduce bioburden and particulate.

Manufacturing & Assembly Expertise Brush pinning Cardiac leads Catheter assembly (flaring, stretching) Component coating De-Burring Electronics assembly Heat staking Hoop assembly (cutting, clipping) Instrument assembly Kit assembly (kitting) Liquid handling & filling Metal staking Riveting Serialized product management Silicone coating Solvent bonding Syringe modification, filling, capping Temperature & time sensitive materials handling Metal and Plastic UHMWPE part assembly Tubing sets (cutting & fitting assembly) UV bonding Medical Tray and Pouch Sealing

Inspection Capabilities CMM Digital calipers Digital dial indicators Flow meters Gauges (force, pressure, temperature, protrusion) Manometers Micrometers Optical comparitor Pin & ring gauges Scales Steel rules Surface roughness Thermometers Toolmaker’s scopes UV intensity meters

For more information on QTS Class 7 cleanroom standards or adherence to FDA medical packaging requirements, contact us.