Testing & Inspection/QA/QC

Testing & Inspection/QA/QC

Apex Computer Systems Inc.

Booth 558

It's familiar Microsoft Office collaboration and productivity tools delivered through the cloud. Everyone can work together easily with anywhere access to email, web conferencing, documents and calendars. It includes business-class security and is backed by Microsoft. Whether you are a small business or multinational enterprise, Office 365 offers plans that are designed to fit your organization's unique needs.

Apex Computer Systems can help your organization with Office 365:
- Pre- Sales Assessments
- 30 Day Trial Support and Proof of Concepts
- Configuration and Go- Live Assistance
- Ongoing Help Desk and User Support

ATC Inc. - Advanced Test Concepts Inc.

Booth 818

Model ME3 is a new generation of our vacuum instruments using ATC's innovative Mass Extraction technology. The ME3 features in-line high speed Container Closure Integrity testing, and offers high speed evacuation circuit for in-line process testing where short test times are required. The ME3 includes an automated vacuum test circuit, uniquely designed for ultra-tight leak testing. It tests for both large leaks and fine leak, displaying the real time pressure and flow rates.

Automatic Manufacturing Ltd.

Booth 1855

Over 25 years experience in design and manufacturing in medical devices, Automatic Manufacturing Ltd. (AML), a member of the AML Holdings Ltd, is a Hong Kong Based company provided turnkey contract manufacturing solution on medical device. AML is an ISO 9001, ISO 13485/EN46001, ISO 14001, and TS16949 certified and cGMP practicing manufacturer with FDA and SFDA registered facilities. With total 750,000 sq ft. manufacturing facilities and over 4000 workers in China, AML has an in-house mold making and plastic injection facilities, 10K/30K/100K clean room environment and in-house bio-burden testing lab to support different production requirement. AML provides innovative, high-quality services to world- class renowned medical and Health Devices Companies.

Benchmark Electronics

Booth 977

Benchmark provided award-winning engineering and manufacturing services for the two devices above. Pictured left is AccuVein's non-invasive medical device used to locate difficult-to-find veins. Pictured right is 3Ms fully integrated molecular diagnostic system which is a real-time Polymerase Chain Reaction thermo cycler. Benchmark Electronics utilizes a fully-integrated development process and provides product design, complete turnkey electromechanical manufacturing, fulfillment services, and custom automated assembly and test equipment solutions. Engineering expertise includes electrical, mechanical, software, test, and optical, along with award-winning Industrial Design and complete NPI process, with a global presence in 23 locations in 10 countries. FDA Registration and QSR Compliant.

Bird Precision

Booth 1261

Bird Precision offers precision orifices and filters. A unique series of laser drilled , wire lapped ruby and sapphire orifices. Orifices and filters are packaged in a huge variety of standard stainless, brass and plastic fittings, connectors and inserts.
Product specifications:

over 150 precision orifice sizes starting at .0004"(10 microns).

"golden Orifice series with .0001" total tolerance.

With extreme chemical and wear resistance these products insure precise dependable control of even the most harsh liquids and gas.

The company continues to focus on putting orifices and filters where you need them, and also provides a number of Swagelok, Parker, Smc and Value Plastic Retrofits.

EP Laboratories Inc.

Booth 840

EP Laboratories, Inc. features its packaging, thin film and flexible barrier testing capabilities which include seal strength, puncture resistance, coefficient of friction, tensile strength and elongation. Testing services for hardness (Rockwell, Vickers, micro, nano), wear, abrasion, nanoindentation, scratch resistance and adhesion are also offered. EP Laboratories, Inc. is an independent lab that specializes in mechanical and physical testing using low loads (micro and nano included), and is committed to providing confidential, professional and detail-oriented services at competitive prices.

Evans Analytical Group

Booth 2083

The analytical team of Evans Analytical Group (EAG) showcases extensive contract testing solutions at Booth #2083, MD&M West 2012. Meet the world leaders in customized analytical support for the medical device industry, including surface analysis, chemical testing, contaminant identification, deformulation, failure analysis, corrosion/defect testing and method development. EAG now offers regulated analytical support, with method validation and transfer, extractables and leachables testing, stability services, regulatory support and drug-device combination testing. With experience analyzing a wide variety of materials, an in-depth knowledge of FDA regulations and ISO 10933 standards, EAG's expert scientists can assist with your challenging product development project.

Healthmark/WestField/Famos

Booth 1997

According to AAMI, the FDA, CDC, CEN, Health Canada, CSA, NHS Estates and other regulatory agencies, validation of medical device cleaning, disinfection and sterilization should be done with "test soils" that are modeled on the soils the medical device is likely to be contaminated with during actual clinical use.

ATS is formulated and based upon experimental data, Artificial Test Soil (ATS) simulates the "worst case" soil level from patient-used medical devices. ATS is a standardized soil formulation that would be applicable to a wide range of medical device simulated-use testing and cleaning validation.

Interface Catheter Solutions

Booth 3119

Interface Catheter Solutions' Auto-i 360 balloon visual inspection system improves quality control by making it easier to find, identify, and classify defects, including gel spots, fish eyes and embedded material. The system provides both visual inspection and dimensional measurements of medical balloons in a single operation. Inspection includes classification and size of defects with pass/fail analysis based on user-selected criteria. The Auto-i 360 system operates with a sophisticated vision system and custom analysis software with an intuitive user interface. The Auto-i 360 system provides immediate detailed visual and data reporting used in both manufacturing and research and development.

KEYENCE Corporation

Booth 1579

The VK-X200 3D Laser Scanning Microscope from KEYENCE Corporation is the latest system used for non-contact 3D surface characterization and roughness measurements. Combining the capabilities of a roughness gauge, electron microscope and optical microscope, the VK-X Series can perform profile, roughness and thickness measurements with 0.5 nm Z-resolution on nearly any material. By rastering a laser across a target, this microscope captures fully-focused images and acquires 3D data on surfaces with angles approaching 90 degrees. A new automation function allows users to scan and measure a target with the touch of a button, dramatically reducing analysis time and eliminating measurement variations between different users.

Lumetrics Inc.

Booth 2249

Lumetrics® - LumetriScan™360 Tubing and Balloon Measurement

When it comes to balloon and tubing thickness measurements, engineers have used traditional pin gauges, micrometers, and razor blades; literally for centuries - and these devices consistently produce error rates higher than 60%. The LumetriScan™ 360 provides a scanning system to take multiple measurements at various locations along the length of a part and at various angular positions. LumetriScan™ 360 allows inflation pressure, of any product, up to 125 psi and higher. Lumetrics® developed a proven, accurate, non-contact measurement system designed to reduce production cycle time and enhance quality control.

Lumetrics Inc.

Booth 2249

Lumetrics® - RoboScan™ Medical Bag Measurement
Blood and IV bags typically are measured manually with touch gauges and razor blades. But these devices are notoriously inaccurate and subject to extreme operator variability. Manufacturers today don't have to settle for sub-prime seal thickness measurements. RoboScan™ provides a method to take thickness measurements at various locations around the seals, and around all tubing. RoboScan™ measures up to 200 samples per second and provides this information in an easy to use graphical interface with process control feedback. Lumetrics® proven, accurate, non-contact measurement system will reduce production cycle time and enhance quality control.

Mahr Federal Inc.

Booth 3069

Mahr Federal has announced the addition of an economical and powerful new skidless surface evaluation system to its MarSurf® line of mobile surface metrology systems. The new MarSurf M 400 features proprietary motorized probe height adjustment which quickly and automatically zeros the probe in seconds and can cut measurement time in half. The M 400 also features a magnetic, breakaway probe mounting system which protects sensitive probes from accidental damage and facilitates fast probe changes. The MarSurf M 400 measures all common international parameters, and features Bluetooth connectivity between the measuring system and the evaluation unit with integrated thermal printer.

S-T Industries Inc.

Booth 3368

S-T Industries, Inc., St. James, MN, manufactures a complete line of optical comparators, video inspection systems and precision measuring tools.

Scienscope International Corp.

Booth 2987

The Xspection 6000 is a Digital fully programmable CNC controlled x-ray inspection system that allows operators to program inspection and measurement routines with point and click ease. Attendees can bring samples to the Scienscope booth #2987 and receive a free product evaluation and sample images on a
USB / SD card.

Standard features include; A 2 inch x 2 inch Digital Flat Panel X-ray detector with 2000 x 2000 pixel resolution, 130 kV- 3 micron x-ray tube, independent Z axis movement of the x-ray tube and image detector, variable speed X-Y stage with 70 degree tilting of the x-ray tube and x-ray detector and a full featured CNC programmable image processing / measurement CPU with 24" LCD flat panel monitor.

TEKTRONIX by Instrument Engineers

Booth 2492

See both the time and RF frequency domains simultaneously with Tektronix MDO4000 Mixed Domain Oscilloscopes, providing the world's ONLY time-correlated trigger, capture and display of a combination of domains. MDO's have 4 analog channels, 16 logic channels, and an integrated, WIDE CAPTURE bandwidth real time Spectrum Analyzer. All channels are fully integrated for universal triggering and acquisition. Capture long time shots of your RF signal to see how your RF changes over time or device state. Search for and mark anomalies. Capture hopping frequencies. ANALYZE EFFICIENTLY. 500 MHz to 1 GHz oscilloscopes with 3 or 6 GHz spectrum analyzer.

Vacuum Instrument Corp./VIC Leak Detection

Booth 1646

VIC-Torr is a high resolution test instrument that can be configured as a mass flow, pressure decay or vacuum decay leak tester and is available in single or multi-channel models. The product can be used for leak and occlusion testing of catheters, IV tube sets, IV and blood bags. The robust high resolution color LCD touch screen provides all the needed information about the test part including, but not limited to rejection rate, leak rate and test time, while the prominently displayed green and red accept and reject indicator light/buttons make it easy to discern if the test product is pass or fail.
VIC-Torr is a high resolution test instrument that can be configured as a mass flow, pressure decay or vacuum decay leak tester and is available in single or multi-channel models. The product can be used for leak and occlusion testing of catheters, IV tube sets, IV and blood bags. The robust high resolution color LCD touch screen provides all the needed information about the test part including, but not limited to rejection rate, leak rate and test time, while the prominently displayed green and red accept and reject indicator light/buttons make it easy to discern if the test product is pass or fail.

Vision Engineering Inc.

Booth 2549

Kestrel Elite is a high accuracy, low investment system, designed to transform your measurement and inspection capabilities. From simple single feature operation, to more complex component part measurement, Kestrel Elite combines high resolution, high contrast images with intuitive microprocessors to deliver accuracy and simplicity for a wide range of measuring applications.

The Kestrel Elite's patented optical viewing head makes accurate measurement easy. The superb optical clarity also allows detailed visual inspection to be performed simultaneously.

VISIONx Inc.

Booth 1843

VISIONx INC. INTRODUCES VISIONGAUGE® DIGITAL OPTICAL COMPARATOR 300 SERIES / FIELD OF VIEW SYSTEM

The desktop 300 Series VisionGauge® Digital Optical Comparators are extremely cost effective desktop systems that are ideal for smaller parts. They have an extended depth of field for tall parts and a long working distance that provides ample clearance and room to work between the part and the lens. The 300 Series have all of the functionality of the 500 Series VisionGauge® Digital Optical Comparator including;

CAD Auto Align and CAD Auto Pass / Fail tools
Works directly with CAD data (no overlay required)
Automatic image and data collection
Built in SPC capability
No moving or consumable parts

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