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Partnering with Medical Device Manufacturers since 2001
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QUALITY TECH SERVICES
Manufacturing Partnership
Lindsey Hagan
Sales Account Manager
Medical Packaging and Assembly Solutions
Package DesignValidationsAssemblyPackagingLabelingSterilization
CoordinationOversee Lab Testing
HISTORY Established in 2001 Doug Wilder CEO 75 Employees Over 100 years of
Combined Medical Device Experience
New Facility Located in Bloomington 54,000 square feet
(versus 18,000) 3,000 sq ft of Cleanroom
(versus 1,800) Enhanced Engineering Lab Expanded Warehouse
Certification TUV Services
ISO 13485 Certified
ISO Class 7 (10,000) Clean Rooms
FDA Compliant
UrologySpineNeurologyOrthopedicsDentalCardiology
Current Market Segments
Applications Balloon Catheters Dental Implants Biopsy Needles Surgical Kits Joint Replacement
Implants
Manufacturing and Assembly Capabilities
Riveting Heat staking Metal Staking De-Burring Solvent Bonding UV Bonding Catheter Assembly (flaring, stretching) Hoop Assembly (cutting, clipping) Brush Pinning Syringe modification, filling, capping Instrument Assembly Electronics Assembly
Kit Assembly (kitting) Component coating Liquid handling & filling Silicon coating Tubing sets (cutting and fitting
assembly) Cardiac Leads Titanium/steel/UHMWPE part assembly Temp & Time Sensitive materials
handling Serialized product management Inventory management Inspection and Testing
Manufacturing & Assembly Capabilities
Package DesignSterile Barrier Design
Tray & PouchShelf BoxShipping CartonLabel Design
Labeling & Validated Printing
EN980 Symbols UCC/EAN & HIBC
Barcodes Language Translation Database Integration
[VPN Connectivity] On-Demand Printing
[Serialization]
Pouch and Tray Sealing
Validations
Seal Validation Cleaning Packaging Sterilization
Cleaning & Passivation
UltraPure Water System [USP 24 or Better]
Detergent CleaningSolvent CleaningPassivation
Document Control
CAD BASED
POD Structure
PROJECT ENGINEER BUYER PLANNER
CUSTOMER
SALES ACCOUNT MANAGER
Project ManagementCustomer Provided Specifications
Top Level Drawing Generated by QTS
Manufacturing Documents Controlled by QTS
Coordinate Validations
Meet Customer Driven Timelines
Quality
On Time Delivery CAPAs Inventory Report“Quality for Life”
Inspection Capabilities Micrometers Toolmaker’s Scopes Steel Rules Pin and Ring Gauges Digital Calipers Gauges (force, pressure,
temperature, protrusion) Digital Dial Indicators Manometers Thermometers Scales Flow Meters UV Intensity Meter
Peel, Dye, Bubble Leak Testing Tensile Strength Testing Surface Roughness Optical Comparitor* CMM*
* subcontract service
Inspection & Test Capabilities
