QTS-Medical Device Packaging and Assembly

QUALITY TECH SERVICES

Manufacturing Partnership

Lindsey Hagan

Sales Account Manager

lhagan@qtspackage.com

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

For more information or a tour Contact:

Lindsey Hagan at lhagan@qtspackage.com

Or call 952-942-8321