Akron Rubber Development Laboratory, Inc.
2887 Gilchrist Road
Akron, OH 44305
Phone: (330) 794-6600
Fax: (330) 794-6610
Web: www.ardl.com
E-mail: info@ardl.com
Contact: Malcolm Wilborn

Services: Akron Rubber Development Laboratory, Inc. (ARDL) is an ISO 9001 registered, A2LA accredited laboratory dedicated to problem solving, independent testing and polymer development. ARDL develops and tests gloves, condoms, medical devices, aseptic elastomers, apparel and much more. ARDL’s services include shelf life testing, chemical analysis, failure analysis, product design analysis and testing for 510(k) submissions and U.S. FDA detentions at point of entry. Concept-to-product development services are available. ARDL’s various departments include engineering, physical, chemical, latex, plastics, microscopy, compounding and mixing. In addition to standard testing, ARDL regularly develops specialized test programs suited to specific customer needs.

AppTec
2540 Executive Drive
St. Paul, MN 55120
Phone: (651) 675-2000/(888) 794-0077
Fax: (651) 675-2005
Web: www.apptec-usa.com
E-mail: info@apptec-usa.com

Services: AppTec’s ISO-certified, FDA-registered laboratories provide comprehensive biosafety testing and contract services for medical devices/products. Testing (GLP/cGMP-compliant) includes biocompatibility (in vivo and in vitro), chronic toxicity, genotoxicity, microbiology, chemistry, sterilization validation, viral clearance, environmental monitoring and package testing. Contract services include cGMP processing/manufacturing for cells, tissues and tissue-engineered products and therapies.

ATI Wah Chang
1600 Old Salem Road, N.E.
P.O. Box 460
Albany, OR 97321
Phone: (541) 967-6913
Fax: (541) 967-6986
Web: www.wahchanglabs.com
E-mail: testingsolutions@wahchang.com
Contact: Bill Beasley

Products and Equipment: LECO, Kjeldahl distillation, inert gas fusion, atomic absorption, cold vapor AA, DCP & ICP-OES, corrosion testing, tensile testing, hardness testing, tormability testing, tube pressure testing, shape memory alloy testing, vacuum heat treatment, microstructure evaluation, metallography, scanning electron microscopy.

Services: Chemistry control and analysis using atomic emission methods; hydrogen and hydride detection using interstitial gas analysis methods, metallography and microscopy; surface contamination detection using microhardness and microscopy to detect alphacase and other light elements; grain size measurement to ASTM E112 using bright field and polarized light microscopy.

Comments: ISO 9001:2000, ISO 17025 and Nadcap accredited.

Biological Test Center (BTC)
2525 McGaw Avenue
Irvine, CA 92614-5895
Phone: (949) 660-3185
Fax: (949) 660-3404
Web: www.biologicaltestcenter.com
E-mail: paul.mazur@bbraun.com
Contact: Paul Mazur

Services: Toxicology, discovery and safety pharmacology, pharmacokinetics, metabolism, biocompatibility, endotoxin, microbiology and particulate matter testing.

Comments: Biological Test Center has served the pharmaceutical and medical device industries with contract laboratory testing since 1980. We perform a wide range of studies in our GLP laboratory, specializing in innovative surgical and opthalmological models.

Bodycote Materials Testing
Canada Inc.
2395 Speakman Drive
Mississauga, Ontario L5K 1B3
Canada
Phone: (905) 822-4111
Fax: (905) 823-1446
Web: www.na.bodycote-mt.com
E-mail: sales@bodycote.com
Contact: Marketing Center

Products and Equipment: As a North American leader in contract research, development and consulting, Bodycote Materials Testing Canada Inc. has been involved in medical device development for over three decades. Our breadth of capabilities and experience allows us to offer comprehensive materials-based product and process development.

Comments: Our strength is our experience in the development of new products and technologies, based on a broad technical knowledge, supported by comprehensive analytical and testing capabilities, using well equipped materials processing laboratories and cleanrooms. For more information please visit us at www.na.bodycote-mt.com.


BSI Management Systems
12110 Sunset Hills Road, Suite 200
Reston, VA 20190-5902
Phone: (703) 437-9000
Fax: (703) 437-9001
Web: www.bsiamericas.com
E-mail: inquiry@bsiamericas.com
Contact: Jenny Pittman

Products and Equipment: BSI, the world’s leading management systems registrar, helps companies improve quality and manage risk through ISO 9001, ISO 13485, CE marking, CMDCAS, medical device testing, US FDA 510(k) review, standards, publications and training courses.


Bulbtronics, Inc.
45 Banfi Plaza, N.
Farmingdale, NY 11735
Phone: (800) 624-2852
Fax: (631) 249-7989
Web: www.bulbtronics.com
E-mail: marketing@bulbtronics.com
Contact: Barbara Kaplan

Products and Equipment: Bulbtronics, leading supplier of bulbs and batteries for equipment and instrumentation, offers four locations with 30,000+ products from 150+ manufacturers. Our OEM department works with design engineers and production to search, ID and source the bulb, battery connector, fuse, starter, ballast, etc. for the application. Bulb technologies include halogen, incandescent, fluorescent, xenon, mercury and more. All battery chemistries and sizes are available as well as scaled lead acid, rechargeables and special battery configurations. For information call 1-800-624-2852 x483 or go to e-commerce site: www.bulbtronics.com.

Centurion Sterilization Services
301 Catrell Drive
Howell, MI 48843
Phone: (866) 386-0530
Fax: (517) 546-3356
Web: www.centurionsterile.com
E-mail: bsparks@tshsc.com

Services: Centurion Sterilization Services provides quality 100% contract EO sterilization. Each facility is ISO 13488 certified with compliance to EN550. Our on-site laboratories help reduce overall costs and lead-time during both routine sterilization and validations. Centurion specializes in turnkey validations available in 6 to 8 weeks. Ask us about our packaging capabilities too!.


Citech
5200 Butler Pike
Plymouth Meeting, PA 19462
Phone: (610) 825-6700
Fax: (610) 834-1275
Web: www.citechtest.com
E-mail: info@citechtest.com
Contact: Robert Monsenkis

Services: Safety and performance testing; environmental testing; third-party 510(k) review.

Comments: Testing services to support 501(k) submissions or marketing programs, third-party 510(k) reviews to save months on new product introduction.


Cold Chain Technologies
29 Everett Road
Holliston, MA 01746
Phone: (508) 429-1395
Fax: (508) 429-9056
Web: www.coldchaintech.com
E-mail: sales@coldchaintech.com
Contact: Rick Cahill

Products and Equipment: Cold Chain Technologies provides shipping solutions for temperature-sensitive applications, including the manufacture and distribution of packaging and shipping products. Cold Chain offers a family of top-quality temperature related products that include refrigerants, insulated containers and temperature indicators. The company also engineers and designs packaging and provides thermal testing services to ensure safe transit of its customers’ products.

Services: Cold Chain Laboratories designs and tests cost-effective, thermally efficient solutions that support specific applications. Cold Chain Laboratories’ goal is to help customers operate a more efficient and robust cold chain process.

Comments: Cold Chain Technologies serves the pharmaceutical, biotech, healthcare and medical device industries as well as food service and other industries with temperature-sensitive applications.


CSA International
8501 E. Pleasant Valley Road
Cleveland, OH 44131-5575
Phone: (216) 524-4900
Fax: (216) 642-3463
Web: www.csa-international.org
E-mail: client.services@csa-international.org
DDL, Inc.
10200 Valley View Road, #101
Eden Prairie, MN 55344
Phone: (952) 941-9226
Fax: (952) 941-9318
Web: www.testedandproven.com
E-mail: pat.nolan@testedandproven.com

Services: Medical device product and package testing services.

Comments: Package/product testing for simulating transportation. Vibration, shock and compression testing. ASTM D3580; D3332; D4169; D642; D999; F88; F1140 and others. DOT-approved third-party testing agency for HazMat package certification; medical device process and package validation (ISO 11607); accelerated aging and thermal conditioning; environmental data acquisition; protective cushion evaluation; random vibration simulation.


Dynatec Scientific Laboratories
11940 Golden Gate Road
El Paso, TX 79936
Phone: (915) 849-1322
Fax: (915) 849-0992
Web: www.dynatec-labs.com

Products and Equipment: Biological indicators, prepared medias, fluid D, indoor air quality kit.

Services: medical device sterility assurance testing, radiation, ethylene oxide, microbial identification.

Comments: The company has operations in the U.S. and Mexico. Dynatec Scientific Laboratories is experienced in international standards. Dynatec is also a manufacturer of environmental kits. FDA registered and ISO/IEC 17025:1999 accredited. EMPAT (microbial identification) accredited.

Ethox Corp.
251 Seneca Street
Buffalo, NY 14204
Phone: (716) 842-4000
Fax: (716) 842-4040
Web: www.ethoxcorp.com
E-mail: info@ethoxcorp.com
Contact: Dick Malo

Products and Equipment: OEM contract manufacturing of disposable medical products.

Services: Process development, injection molding, RF and impulse welding, ultrasonic welding, assembly, in-house sterilization and lab service packaging.

Comments: We can take your product from design to prototype to production to packaging to sterilization back to the customer. No job too small or too big.

Fallbrook Engineering, Inc.
28000 Via Viso
Valley Center, CA 92082
Phone: (800) 906-6789
Fax: (760) 751-1200
Web: www.fallbrook-eng.com
E-mail: dickm@fallbrook-eng.com
Contact: Richard Meyst

Products and Equipment: Verification and validation testing of functional aspects of medical devices and instruments.

Services: Benchmark testing of competitive products as well as testing of vendor components and assemblies.

Comments: Custom programs as needed.


Geneva Laboratories, Inc.
P.O. Box 140
1001 Proctor Drive
Elkhorn, WI 53121
Phone: (262) 723-5669
Fax: (262) 723-4015
Web: www.genevalabs.com
E-mail: custservice@genevalabs.com
Contact: Pat Brotzman

Comments: Well known for excellence in quality medical device testing, Geneva Laboratories offers a full spectrum of testing services, biocompatibility, microbiology, toxicology, chemistry, sterility assurance and validation, pre-market testing, package integrity testing and more. Geneva Labs will provide dependable service, accurate test reports, prompt and professional testing to assure safety and compliance. ISO 9002 and EN certified. GLP/cGMP compliant. FDA registered.


Gibraltar Laboratories, Inc.
122 Fairfield Road
Fairfield, NJ 07004
Phone: (973) 227-6882
Fax: (973) 227-0812
Web: www.gibraltarlabsinc.com
E-mail: danielprince@gibraltarlabsinc.com
Contact: Dr. Herbert Prince

Services: Research and quality control test services in bacteriology, myeology and virology as well as chemistry and in-vitro toxicology for the device, pharmaceutical and biotech industries. Extensive experience in contamination control, AAMI sterility, test methods as well as USP and ASTM methodology. FDA registered since 1970. ISO 17025 accredited.


Glenbrook Technologies, Inc.
11 Emery Avenue
Randolph, NJ 07869
Phone: (973) 361-8866
Fax: (973) 361-9286
Web: www.glenbrooktech.com
E-mail: jclymer@glenbrooktech.com
Contact: Jonathan Clymer

Products and Equipment: Glenbrook Technologies manufactures high-resolution, real time x-ray inspection systems for quality assurance of medical devices.

Comments: Glenbrook x-ray inspection systems are ideal for inspection of low-density materials such as plastics, collagen, urethanes and rubbers.


IMR Test Labs
131 Woodsedge Drive
Lansing, NY 14882
Phone: (888) 464-8422
Fax: (607) 533-9210
Web: www.imrtest.com
E-mail: imr@imrtest.com
Contact: Jeff Zerilli

Services: Failure analysis, reverse engineering and reliability testing of medical devices. IMR also offers basic metallurgy, SEM/EDS, chemical analysis, mechanical testing of metallic and non-metallic materials.

Comments: Other locations include Charleston, SC and Louisville, KY.

Interpower Corp.
P.O. Box 115
Oskaloosa, IA 52577
Phone: (800) 662-2290
Fax: (800) 645-5360
Web: www.interpower.com
E-mail: info@interpower.com
Contact: Customer service

Products and Equipment: North American and International cord sets and power cords; power entry modules; North American and International plugs and sockets; isolation transformers.

Comments: Interpower Corporation has a full line of power system components including hospital-grade cord sets, medical power entry modules, power cords, medical power transformers and power components for the international market place.


KMC Systems, Inc.
220 Daniel Webster Highway
Merrimack, NH 03054
Phone: (603) 886-7501
Fax: (603) 594-7022
Web: www.kmcsystems.com
E-mail: kcushman@kollsman.com
Contact: Kim Cushman

Comments: KMC Systems designs, develops and manufactures medical device instrumentation, including diagnostic, therapeutic and biomedical products. With more than 25 years of contract manufacturing experience, the ISO 9001-and ISO 13485-certified and FDA- registered firm has expertise in all aspects of product and development, validation and design for production. Capabilities include flexible turnkey manufacturing with full warranty and depot support and full compliance with FDA QSR regulations and GMP practices.

Lacey Manufacturing, Inc.
1146 Barnum Avenue
Bridgeport, CT 06610
Phone: (203) 336-7442
Fax: (203) 336-1774
Web: www.laceymfg.com
E-mail: cmikita@laceymfg.com
Contact: Craig Mikita

Products and Equipment: Contract manufacturer.

Services: Design, molding, assembly and packaging.

Machine Solutions Inc.
2901 West Shamrell Blvd., Suite 107
Flagstaff, AZ 86001
Phone: (928) 556-3109
Fax: (928) 556-3084
Web: www.machinesolutions.org
E-mail: info@machinesolutions.org

Products and Equipment: Stent crimping, electrode crimping, balloon catheter pleating and folding, marker band swaging, interventional device track equipment, radial expansion force measurement equipment, thermal shrinking equipment, catheter and stent testing equipment.

Services: Contract testing services including trackability testing, pushability testing, crossability testing, torque testing and hoop force measurement.

Comments: The contract testing services from MSI provide unique, self-contained solutions for catheter and stent testing. Criteria being analyzed can have a direct impact on product design and can be used to satisfy FDA submissions. Our proprietary testing equipment puts an emphasis on improving repeatability and increasing accuracy and resolution.


Mark-10 Corp.
11 Dixon Avenue
Copiague, NY 11726
Phone: (631) 842-9200
Fax: (631) 842-9201
Web: www.mark-10.com
E-mail: vs@mark-10.com
Contact: Vera Sabov

Products and Equipment: Mark-10 Corporation Manufactures force and torque measuring instruments used in materials testing, product qualification and R&D. Applications include peel force measurement, seal and joint strength determination, needle and blade sharpness measurement, bottle cap torque measurement, etc.


Medical Device Consultants, Inc.
49 Plain Street
North Attleboro, MA 02760
Phone: (508) 643-0434
Fax: (508) 643-2237
Web: www.mdci.com
E-mail: info@mdci.com
Contact: Bill Morton

Services: Regulatory, clinical and QA consulting services

Comments: Medical Device Consultants, Inc. (MDCI) helps medical device, in-vitro diagnostic and biotechnology clients overcome the regulatory, clinical and QA challenges of bringing new medical technology to market.


Medical Device Safety Service GmbH
Burckhardstrasse 1,
D-30163 Hannover, Germany
Phone: (49) 511-62628630
Fax: (49) 511-62628633
Web: www.mdss.com
E-mail: info@mdss.com
Contact: Ludger Moeller

Services: Regulatory services, risk management, technical documentation, auditing, inspections, conformity assessment, equipment safety and product certification. Comments: MDSS specializes in European regulatory affairs. As the European authorized representative, the firm acts on behalf of its clients and it is required by the European directives according the MDD, AIMDD, IVDD, Cosmetics and PPE. The service includes product registration, incident and recall reporting, labeling and technical file consulting. MDSS interacts with the Commission, the national authorities and distributors.

NAMSA
6750 Wales Road
Northwood, OH 43619
Phone: (866) 666-9455
Fax: (419) 662-4386
Web: www.namsa.com
E-mail: info@namsa.com
Contact: Terry Langenderfer

Comments: For over 35 years, NAMSA has been a world leader specializing in the safety evaluation of medical devices. Our unique combination of preclinical and clinical expertise means we deliver the most cost effective testing programs that satisfy regulatory requirements worldwide. All NAMSA laboratories are fully certified and accredited according to the highest industry standards.


Nelson Laboratories, Inc.
6280 S. Redwood Road
Salt Lake City, UT 84123
Phone: (800) 826-2088
Fax: (801) 963-2630
Web: www.nelsonlabs.com
E-mail: sales@nelsonlabs.com
Contact: Martell Winters

Services: Nelson Laboratories is an independent test services provider specializing in microbiology, sterilization validations, lot release tests (sterility, bioburden, B/F, pyrogen, etc.), biocompatibility, organism identification, residuals, filter validations and much more. With our 62,000 sq. ft. facility we maintain 80 labs, a custom built 3,000 sq. ft. sterility testing cleanroom suite. Nelson employs more than 180 staff members including more than 70 degreed scientists among whom are 30+ registered and specialist microbiologists (NORM).


Northview Biosciences, Inc.
1880 Holste Road
Northbrook, IL 60062
Phone: (847) 564-8181
Fax: (847) 564-8269
Web: www.northviewlabs.com
E-mail: info@northviewlabs.com
Contact: Laura Ritter

Services: Northview is an independent laboratory offering GMP/GLP testing services to medical device, pharmaceutical and biopharm industries since 1972. Northview specializes in sterility assurance, biocompatibility, preclinical toxicology and pharmacology services. Northview is ISO 9001 certified and AAALAC accredited with facilities located in Northbrook, IL, Hercules, CA and Spartanburg, SC.


Plexus Corp.
55 Jewelers Park Drive
P.O. Box 156
Neenah, WI 54957-0156
Phone: (920) 751-3605
Web: www.plexus.com
E-mail: plexus_marketing@plexus.com
Contact: Brad Goskowicz, medical VP

Products and Equipment: EMS services for medical product OEMs.

Services: Advanced medical product design, new product introduction, contract manufacturing, test and sustaining services.

Comments: 25 years of advanced medical product design and manufacturing of Class I, II and III medical products. Plexus is recognized and awarded for customer service excellence, providing global design and manufacturing solutions. Visit us at www.plexus.com.


Proven Process Medical Devices
141 Washington Street
East Walpole, MA 02032
Phone: (508) 660-9045
Fax: (508) 660-6946
Web: www.provenprocess.com
E-mail: info@provenprocess.com
Contact: Kenneth Fine

Services: Product design and development, product testing and design verification, prototyping, software development and validation, contract manufacturing, assembly and packaging.

Comments: Proven Process Medical Devices is an ISO 13485-certified, full service outsourcing partner that provides exceptional design, development, validation, testing and contract manufacturing services exclusively for the medical device industry. With a broad range of experience designing, validating and manufacturing novel Class II and Class III therapeutic and diagnostic medical products, Proven Process is uniquely qualified to assist you from concept to your customer’s door and anywhere in between.


Raven Biological Laboratories
8607 Park Drive
Omaha, NE 68127-3623
Phone: (402) 591-0781
Fax: (402) 593-0921
Web: www.ravenlabs.com
E-mail: info@ravenlabls.com
Contact: Dan Dwyer

Products and Equipment: Biological and chemical indicators.

Services: D value resistance studies, custom RI manufacturing, microbial ID and population analysis.

The Realtime Group
3035 W. 15th Street
Plano, TX 75075
Phone: (972) 985-9100
Fax: (972) 985-9150
Web: www.therealtimegroup.com
E-mail: marshall@therealtimegroup.com
Contact: Marshall Wenrich

Products and Equipment: Customized test plans and procedures to meet QSR for design verification and validation.

Services: Independent verification and validation including test procedures, test execution and test reports.

Comments: Performs IQ/OQ/PQ manufacturing process validation; also specializes in electromechanical and software intensive product validation.


Specialty Coating Systems
7645 Woodland Drive
Indianapolis, IN 46278
Phone: (317) 244-1200
Fax: (317) 240-2092
Web: www.scscookson.com
E-mail: cgillespie@cooksonelectronics.com
Contact: Carla Gillespie

Products and Equipment: Ionic contamination test systems.

Services: Ionic contamination test services.

Comments: SCS systems includes omegameter and ionograph test systems which test by static and dynamic processes. Operating software is also available at SCS.


STS duoTEK, Inc.
370 Summit Point Drive
Henrietta, NY 14467
Phone: (585) 321-5000
Fax: (585) 321-3058
Web: www.stsduotek.com
E-mail: info@stsduotek.com
Contact: Gerry Whitbourne

Products and Equipment: As a major distributor of biological indicators, STS provides products in a variety of species and populations for steam, ethylene oxide, dry heat and radiation processes. We offer Process Control Device (PCD) development studies to aid those clients who are seeking their use in validation and routine production processing.

Services: Laboratory services; contract sterilization services; assembly and packaging services.

Comments: STS lab testing experts create certainty around your medical device. By developing comprehensive testing protocols, we provide reports that you can act on with confidence. And that goes for our sterilization, assembly and packaging services as well.


TUV America Inc.
5 Cherry Hill Drive
Danvers, MA 01923
Phone: (800) TUV-0123
Fax: (978) 762-7637
Web: www.TUVamerica.com
E-mail: info@tuvam.com
Contact: Sales

Products and Equipment: TUV America Inc., Product Service Division, is a leading EU notified body for the medical devices, active implantable medical devices and in-vitro diagnostic directives. TUV is an SCC-qualified ISO 13485 registrar for the Canadian Medical Device Regulations and provides FDA 510(k) reviews and third-party inspections. In addition, TUV provides NRTL certification to ANSI/UL 2601, electromagnetic compatibility (EMC), electrical, mechanical and functional safety testing, ISO 9001, ISO 13485, EN 46000 and ISO 14001 quality system certifications and additional global conformity assessments.


Ventrex, Inc.
3007 Bunsen Avenue, Building K
Ventura, CA 93003
Phone: (805) 658-2984
Fax: (805) 658-6720
Web: www.ventrexinc.com
E-mail: bguthrie@ventrexinc.com
Contact: Bob Guthrie

Products and Equipment: Full-service medical device and instrument contract manufacturing Class I, II and III.


Vinatoru Enterprises, Inc.
230 West Parkway, Unit 7-1
Pompton Plains, NJ 07444
Phone: (973) 616-6800
Fax: (973) 616-9444
Web: www.vinatoru.com
E-mail: info@vinatoru.com
Contact: Mihai A. Vinatoru

Products and Equipment: Testing instruments, seal strength seal testing and monitoring software simulated ship testing.

Services: Package testing and evaluation, barrier materials assessment (WVTR and OTR).