Contract testing services and equipment directory: the following directory lists suppliers that provide contract testing services and equipment to the medical device industry. Advertisers are listed in bold and are accompanied by their company logos.

Akron Rubber Development

Laboratory, Inc. (ARDL)

2887 Gilchrist Road

Akron, OH 44305

Phone: [phone]; (866) 788 ARDL

Fax: [phone]

Web: www.ardl.com

E-mail: [e-mail]

Contact: Mac Wilborn or Aria Barbur

Services: Services include but are not limited to chemotherapy resistance; shelf-life and service-life prediction; chemical and physical testing; failure analysis; testing for 510(k) submissions and US FDA detentions; FDA approval and compliance testing; USP physicochemical testing and extractables and leachables studies. ARDL can test many products and compounds including gloves, condoms, aseptic elastomers, apparel, medical devices and more. ARDL also specializes in product and materials development. ARDL utilizes a proven, quality based medical product development process to transform your product concepts into reality. Our three-phase process has resulted in the successful commerdalization of medical products for some of the largest medical device manufacturers in the world. Project managers at ARDL work with clients to develop project schedules that include well-defined tasks and milestones for each phase of development.

Comments: ARDL is an ISO 9001:2000-registered, A2LA-accredited, independent testing, development and problem-solving laboratory serving the robber, plastic and latex industries. Services include shelf life, chemical, physical, failure analysis, testing for 510(k) submissions and US FDA detentions, USP physicochemical testing, extractables and leachables studies and many more.

AppTec

2540 Executive Drive

St. Paul, MN 55120 USA

Phone: [phone]

Fax: [phone]

Web: www.apptec-usa.com

E-mail: [e-mail]

Contact: Dean Enrooth

Services: AppTec's ISO-certified, FDAregistered laboratories provide GLP/ GMP-compliant testing that includes services to ensure your medical device is manufactured, sterilized and packaged in accordance with GMP guidelines; all the relevant test modalities used to study biological safety and biocompatibility; specialized testing for combination/convergent-technology products. In addition, AppTec's single-source platform features cGMP manufacturing services/aseptic processing for specialty device, combination and tissue-based products. AppTec also offers cGMP contract manufacturing and GLP/GMPcompliant testing services for biopharmaceuticals and cellular therapeutics.

Battelle Medical Device Solutions

505 King Avenue

Columbus, OH 43201

Phone: [phone]

Fax: [phone]

Web: www.battelle.org/medical

E-mail: [e-mail]

Contact: Kevin Taylor

Products and Equipment: Comprehensive set of R&D services. Services: Applied research, device development, clinical research and sustaining engineering. Truly integrated engineering and life sciences as well as industrial design and human factors engineering focused in medical design and development.

Biological Test Center

2525 McGaw Avenue

Irvine, CA 92614

Phone: [phone]

Fax: [phone]

Web: www.biologicaltestcenter.com

E-mail: [e-mail]

Contact: Valerie Ackley

Products and Equipment: 32,000-square-foot, AALAC-accredited, GLP-compliant animal facility with 30 holding rooms, eight quarantine rooms, HEPA surgical suites and necropsy suites, full range of ophthahnic diagnostic equipment, PK wet lab and chemistry labs.

Services: Safety/toxicity, ophthahnic surgery, models of ophthalmic disease, pharmacokinetics, metabolism, ocular pharmacology, efficacy, drag discovery and radiolabeled PK studies.

Biotest Laboratories, Inc.

8990 Springbrook Drive NW Suite 100

Minneapolis, MN 55433

Phone: [phone]

Fax: [phone]

Web: www.biotestlabs.com

E-mail: [e-mail]

Contact: Joy Mosley

Services: Validation planning/PMA submission preparation, manufacturing (blending, filling, assembly, packaging), steam sterilization, sterilization validation, laboratory testing (bioburden, LAL, sterility), controlled environmental monitoring and microbial management.

Comments: The cornerstone of Biotest Laboratories' client relationships is to provide quality processes to meet client specifications. It is our belief that our quality systems should equal or exceed the system of our clients. We are your business partner in processing your products. (FDA, ISO 13485:2003, ISO/IEC 17025:2005, EN 554).

Bodycote Testing Group

2395 Speakman Drive

Mississauga, Ontario L5K 1B3

Canada

Phone: [phone]

Fax: [phone]

Web: www.bodycotetesting.com

E-mail: [e-mail]

Contact: Marketing Center

Products and Equipment: As a North American leader in contract research, development and consulting, Bodycote Testing Group has been involved in medical device devel opment 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.bodycotetesting.com.

BSI Management Systems

12110 Sunset Hills Road, Suite 200

Reston, VA 20190

Phone: [phone]

Fax: [phone]

Web: www.bsiamericas.com

E-mail: [e-mail]

Contact: Todd Moorman

Comments: BSI Management Systems is the world's leading management systems registrar. BSI has registered over 60,000 companies worldwide to ISO 9000, QS-9000, ISO/TS 16949, ISO 14001 and many other management systems. BSI also is the leading registrar and notified body in the medical device community-helping companies to improve quality and manage risk through ISO 13485, CE Marking, Japan PAL, medical device testing, US FDA 510(k) review, CMDCAS accreditation, standards, publications and training courses.

Centurion Sterilization Services

301 Catrell Drive

Howell, MI 48843

Phone: [phone]

Fax: [phone]

Web: www.centurionsterile.com

E-mail: [e-mail]

Services: Centurion Sterilization Services provides quality 100% contract EO sterilization. Each facility is ISO 13485 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 six to eight weeks. Ask us about our packaging capabilities, too.

CITECH

5200 Butler Pike

Plymouth Meeting, PA 19462

Phone: [phone]

Fax: [phone]

Web: www.citechtest.com

E-mail: [e-mail]

Contact: Robert Mosenkis

Services: Performance and safety testing of medical devices and components, thirdparty review of eligible 510(k) submissions. Comments: CITECH tests medical devices only. We have many years of testing to support 510(k)s, and we understand FDA requirements and expectations.

Cold Chain Technologies

29 Everette Street

Holliston, MA 01746

Phone: [phone]

Fax: [phone]

Web: www.coldchaintech.com

E-mail: [e-mail]

Contact: Donald No]de

Products and Equipment: Cold Chain Technologies is dedicated to supporting your cold chain needs with the most effective and efficient thermal packaging solutions. Our world-class manufacturing, R&D, project management, product quality and excellent customer support all contribute to the successful operation of customer's cold chain. It's our mission to offer a global, comprehensive one-stop source for design, testing and manufacturing of our thermal packaging products.

Services: Cold Chain Laboratories is a premier source for expert thermal mapping, design, qualification testing and implementation of cold chain solutions. We've designed more than 4,000 thermal pack age designs in our Boston-area lab that's cGMP compliant, ISTA certified and ASTM D3101 maintained. Our lab features multiple wide-range walk-in temperature chambers that can handle multiple LD3 and even LD9 containers. Cold Chain's highly accredited team of engineers build on their experience with SolidWorks software, our vast database of designs and KoolDesigns, our proprietary thermal modeling software. We create efficient solutions to meet your diverse time, temperature and capacity challenges.

Comments: Cold Chain Technologies (CCT) is a leading source for engineering-based thermal packaging solutions. CCT provides thermal packaging products and services to a wide range of customers including pharmaceutical, biotech, healthcare, medical device and foodservice companies. The product line includes KoolTemp insulated containers, Koolit refrigerants and KoolWatch temperature indicators.

Cyanta Analytical Laboratories

2662 Metro Boulevard

Maryland Heights, MO

Phone: [phone]

Fax: [phone]

Web: www.cyanta.com

E-mail: [e-mail]

Contact: Mark Crain

Services: Inhalation and nasal product development; extractables and leachables; analytical methods development and validation; stability programs; reference stand characterization; impurity profiles, degradation and containment studies; and product and manufacturing investigations.

Comments: Cyanta Analytical Laboratories provides inhalation and nasal product development services, as well as analytical support to the pharmaceutical biotech and medical device industries. We are a member of the Azopharma Product Development Group of companies, which provides total product development from preclinical assessments to commercialization. Our facilties are FDA registered, cGMP/GLP compliant and DEA licensed.

DDL Inc.

10200 Va]]eyView Road

Eden Prairie, MN 55344

Phone: [phone]

Fax: [phone]

Web: www.testedandproven.com

E-mail: [e-mail]

Services: Distribution simulation; medical device package integrity and strength testing; product physical testing; material characterization testing; environmental testing; ISO 11607 compliance testing; package design and prototyping services.

Comments: DDL is a well-established expert in medical device package and product testing, offering a full range of package, product and environmental testing services--from accelerated aging testing, shelf life studies and microbial barrier testing to distribution simulations and package integrity and strength and material characterization testing. DDL professionals have worked with clients in the chemical, electronics, mechanical aerospace, medical device, packaging and automotive industries. Our client roster includes many industry leaders and research laboratories.

Ethox International, Inc.

251 Seneca Street

Buffalo, NY 14204

Phone: [phone]

Fax: [phone]

Web: www.ethoxint.com

E-mail: [e-mail]

Contact: Richard J. Malo

Comments: Capabilities cover entire life cycle from design, development and prototyping to fully validated production processes and products; including material sourcing, safety testing, manufacturing, unique Radio Frequency semi-automated and automated processes for peripheral, stub and tube sealing, hot-stamping with quick changeover capabilities, packaging design and testing, sterilization and all related laboratory services.

Geneva Laboratories, Inc.

P.O. Box 140

Elkhorn, W153121

Phone: [phone]

Fax: [phone]

Web: www.genevalabs.com

E-mail: [e-mail]

Contact: Laura Torhorst

Comments: Well known for excellence in quality medical device testing, Geneva Laboratories offers a hill spectrum of testing services--biocompatibility, microbiology, toxicology, chemistry, sterility assurance and validation, pre-market testing, package integrity testing and more. Geneva Laboratories will provide dependable service, accurate test reports, prompt and professional testing to assure safety and compliance. ISO 9001 and 17025 certified, GLP/cGMP compliant, FDA registered.

Gibraltar Laboratories, Inc.

122 Fairfield Road

Fairfield, NJ 07004

Phone: [phone]

Fax: [phone]

Web: www.gibraltarlabsinc.com

Contact: Dr. Daniel Prince

Seraices: PhD-supervised device, biotechnology and pharmaceutical testing in analytical chemistry, ETO, HPLC, GC, AA, methods, products and raw materials, EPA disinfectant testing, USP microbiology, stability, package integrity, contamination control, AAMI sterility methods 1,2, VD-max, wound care and antimicrobial device research including drug-resistant bacteria, identification of microorganisms, virology, human and adventitous agents, cytotoxidty and tissue culture studies. The company, in its fourth decade, is A2LA and ISO certified and operates from two locations in Fairfield, NJ. The expanded second facility in Fairfield provides 16,000 square feet dedicated to clean room and sterility technology including a certified BSL-3 laboratory for infectious disease and virus testing and other special studies.

Comments: Agents, analytical chemistry, GC, HPLC, FTTR and methods validation.

IncisionTech

IncisionTech

9 Technology Drive

Staunton, VA 24401

Phone: [phone]

Fax: [phone]

Web: www.incisiontech.com

E-mail: [e-mail]

Contact: Bob Walden

Products and Equipment: IncisionTech manufactures the sharpest incisional components and assemblies for endoscopic, cardiovascular, ophthalmic, orthopedic and diagnostic procedures. Products include endoscopic scissors, surgical blades, sharpened tubes, tissue cutters, biopsy punches, cannula, trocars, lancets, aortic punches, dissectors, curettes, hypo tubes, stylets, vessel cutters, cutting forceps, custom scalpels, harmonic scalpels, bone saws, combination tools, specialty and access needles, introducers, ultrasonic tips, shaver blades and electro-surgical components.

Services: Our proprietary processing techniques using the latest CNC sharpening and pointing equipment in combination with leading edge electrochemical finishing technology enables IncisionTech to supply the most critical components. Services indude sharpening, pointing, electro-chemical edge enhancement, electro-chemical deburring, starnping/rnachining]heat trealing, grinding, EDM, photo etching, forming/deburring, cleaning and passivation, performance enhancing coatings, laser cutting]welding/marking, overmolding, design assistance for new products, custom packaging]assembly and our IndsionLab. Comments: What makes IncisionTech different from another company that sells specialty blades, trocars, biopsy or aortic punches, tissue cutters or custom needles? We make surgical devices better. While other companies make parts, we make a difference!

Machine Solutions Inc.

2951 West Shamrell Boulevard, Suite 107

Flagstaff, AZ 86001

Phone: [phone]

Fax: [phone]

Web: www.machinesolutions.com

E-mail: [e-mail]

Products and Equipment: Stent crimping, balloon catheter pleating and folding, marker band swaging, tube processing, spray coating, balloon blowing/forming, catheter and stent testing.

Services: The MSI contract testing services will quantitatively analyze catheter and stent performance features such as trackability and pushability as well as measure and record radial force or hoop strength during expansion and compression of interventional devices including balloon expandable and self expanding stents and stent graft products, collagen plugs, embolic filters, vena cava filters and other basket type filter products. The MSI catheter and stent contract testing services are designed to meet ASTM and ISO guidance documents and ASTM test methods. Testing protocols are designed in close collaboration with customers and are designed to comply with the FDA guidance document requirements for non-clinical tests and recommended labeling for intravascular stents and associated delivery systems issued in January 2005.

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.

Medical Device Safety Service GmbH (MDSS)

Schiffgraben 41, 30175

Hannover, Germany

Phone: [phone]

Fax: [phone]

Web: www.mdss.com

E-mail: [e-mail]

Contact: Ludger Moeller

Products and Services: Acting as an interface to EU authorities, product registration with EU Competent Authorities, assistance with Technical File Documentation, advice on European labeling requirements, product vigilance and recall notification, assistance with conformity assessment, procedures and QM systems, in-house training, clinical trial management.

Comments: MDSS specializes in European regulatory affairs. MDSS acts on behalf of its clients as "Authorized Representative" according to the European CE marking regulation IVDD 981791EC, MDD 931421EEC, and AIMDD 90/385/EEC. Certified to EN ISO 13485--MDSS provides support and consultation in product registration, incident reporting, recall management, labeling, instructions for use and technical files, etc.

NAMSA

6750 Wales Road

Northwood, OH 43619

Phone: [phone]

Fax: [phone]

Web: www.namsa.com

E-mail: [e-mail]

Contact: Terry Langenderfer

Products and Equipment: Biological and chemical indicators.

Services: Consulting--medical device, pharmaceutical and biotech.

Comments: For more than 40 years, NAMSA has been a world leader specializing in the safety evaluation of medical devices. Our unique combination of predinical 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: [phone]

Fax: [phone]

Web: www.nelsonlabs.com

E-mail: [e-mail]

Contact: Jason Smith

Comments: Nelson Laboratories is an independent test services provider specializing in microbiology, sterilization validations, packaging tests, lot release tests (sterility, bioburden, particulates, pyrogen, etc.), biocompatibility, organism identification, residuals, reusable device studies and environmental monitoring. Within our 62,000-square-foot facility, we maintain 80 specialty labs and a custom-built 3,000-square-foot sterility testing cleanroom suite. Nelson employs more than 285 staff members, including more than 110 degreed sdentists--among whom are more than 45 registered and specialist microbiologists (NRM).

Raven Labs

8607 Park Drive

P.O. Box 27261

Omaha, NE 68127

Phone: [phone]

Fax: [phone]

Web: www.ravenlabs.corn

E-mail: [e-mail]

Contact: Dan J. Dwyer

Products and Equipment: Raven manufactures biological Indicators for validating sterilization processes. Prospore Ampoule, Prospore2 and ProTest (SCBI's), ProPACT for the System 1, spore strips, suspensions, specialty carriers and BIs, incubators, chemical indicators and integrators and BIER testing services comprise the most complete line of sterility assurance products/services available from a single manufacturer.

Services: Raven performs steam, dry heat, plasma and EO resistance/development studies according to USP/AAMI/ISO recommended procedures. Raven can inoculate your product and perform Dvalue analysis using our AAMI compliant BIER vessels or Sterrad 200 GMP. Raven can verify a compefitor's claim for population and Zvalue/Dvalue using Spearman Karber or survival curve methods.

TMElectronics

45 Main Street

Boylston, MA 01505

Phone: [phone]

Fax: [phone]

Web: www.tmelectronics.com

E-mail: [e-mail]

Contact: Dean Andrews

Products and Equipment: Leak testers, leak/flow or leak/occlusion testers, package testers (seal strength and package integrity), non-destructive test systems for non porous products or packages, custom test fixtures.

Comments: Introducing the new TME Worker Leak, Leak/Flow or Leak/Occlusion Tester, affordable, high-resolution, repeatable, easy-to use benchtop instrument with PLC controls for semiautomatic operation and two-way RS232 communication capability for downloadable program selection and upload-able data.