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 Ana Barbur

Services: Services include, but are not limited to chemotherapy and chemical resistance; shelf-life and service-life prediction; chemical testing and analysis; physical and mechanical testing; failure analysis; testing for 5100(k) submissions and U.S. 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 compound and material development.

Comments: ARDL is an FDA-registered, A2LA-accredited and ISO 9001:2000-registered independent testing, development and problem-solving laboratory, specializing in polymer-related materials used within medical devices.

Azopharma Contract Pharmaceutical Services, Inc.

2 Oakwood Boulevard, Suite 170

Hollywood, FL 33020

Phone: [phone]

Fax: [phone]

Web: www.azopharma.com

E-mail: [e-mail]

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

Comments: Azopharma Contract Pharmaceutical Services, Inc. provides inhalation and nasal product development services, as well as analytical and formulation services 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 discovery to commercialization. Our facilities are FDA-registered, cGMP/GLP-compliant and DEA-licensed.

Battelle Medical Device Solutions

505 King Avenue

Columbus, OH 43201

Phone: [phone]

Fax: [phone]

Web: www.battelle.org/medical

E-mail: [e-mail]

Contact: Dave Giles

Products and Equipment: Comprehensive set of R&D services.

Services: Applied research, device development, manufacturing 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, till range of ophthalmic diagnostic equipment, PK wet lab and chemistry labs. Services: Safety/toxicity, ophthalmic surgery, models of ophthalmic disease, pharmacokinetics, metabolism, ocular pharmacology, efficacy, drug 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: Medical product laboratory testing, validation planning, manufacturing, steam sterilization, 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/ISO 17665).

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 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.bodycotetesting.com.

BSI Management Systems 

12110 Sunset Hills Road, Suite 200

Reston, VA 20190

Phone: [phone]

Fax: [phone]

Web: www.bsiamerica.com

E-mail: [e-mail]

Contact: Todd Moorman

Products and Equipment: CE Marking, Product testing, product certification, kitemark, standards registrar, training, entropy software.

Services: Training.

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, M148843

Phone: [phone]

Fax: [phone]

Web: www.centurionsterile.com

E-mail: [e-mail]

Services: Centurion Sterilization Services provides quality 100 percent 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.

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, third-party review of eligible 510(k) submissions. Comments: CUECH tests medical devices only. We have many years of testing to support 510(k)s, and we understand FDA requirements and expectations.

COGMEDIX

70 Hartwell Street

West Boylston, MA 01583

Phone: [phone]

Fax: [phone]

Web: www.cogmedix.net

E-mail: [e-mail]

Contact: Chris Coughlin

Products and Equipment: Cogmedix focuses on the production of Class I and Class II medical and clinical devices and offers full shipping and fulfillment services.

Services: Cogdemix collaborates with innovative companies bringing new medical and clinical products to the market. Cogmedix aligns itself with companies seeking a compliant, conscientious, cost effective, domestic manufacturing and fulfillment resource to assist them with volume turnkey manufacturing. Cogmedix also serves as a resource to large medical device OEMs who are looking to transition medical devices, currently built at an internal facility or another contract manufacturer, to a compliant and competent manufacturing resource.

Comments: Cogmedix focuses on companies with device manufacturing opportunities of 50 to 5,000 units per year. Cogmedix is committed to maintaining full compliance in accordance with regulatory requirements.

Cold Chain Technologies

29 Everette Street

Holliston, MA 01746

Phone: [phone]

Fax: [phone]

Web: www.coldchaintech.com

E-mail: [e-mail]

Contact: Donald Nolde

Products and Equipment: We're dedicated to supporting your global cold chain through the design and manufacture of high quality, cost-effective, efficient thermal packaging solutions. All of our products are manufactured with materials that meet or exceed the standards of USDA, HACCP, DOT, and all major carriers including FedEx and UPSTM. We offer a full line of proven thermal products, including:.

* KoolTemp GTS pre-qualified solutions

* KoolTemp insulated containers (PUR, molded EPS, panel sheet EPS, pallet shippers)

* Koolit refrigerants (gel packs, bricks, and bottles)

* A variety of temperature indicators and loggers (such as HOBO data loggers and KoolWatch indicators)

Our line includes stock sizes that are ready for immediate shipment and many options for custom sizes and printing. We distribute from multiple locations throughout the United States and internationally. Our products are also available from VWR International. Pharmaceutical, biotech, healthcare, medical device, and food service companies count on us to solve their cold chain challenges. Services: Our Engineering and Technical Services group at Cold Chain Technologies is a package design and package testing company whose objective is to design and test cost-effective, thermally efficient solutions that support your specific applications. Our multidisciplinary design team works on a focused, fasttrack to understand and define your opportunities. Our goal is to help you operate a more efficient and robust cold chain process. At Cold Chain we know that the product you pack on the inside is as important to you as the package is to us.

Comments: Cold Chain Technologies--a global, comprehensive one-stop source for design, testing, manufacturing and distribution of temperature-sensitive products--supports its customers' cold-chain needs with effective and efficient thermal packaging solutions. Manufacturing, R&D, project management, product quality, and excellent customer support all contribute to the successful operation of our customers' cold chain.

DDL Inc.

10200 Valley View 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's technical experts are industry leaders in medical device package, product and material validation (ISO 11607) and can help ensure that you comply with industry standards and regulations. DDL offers a full range of testing service from accelerated aging, shelf-life studies and microbial barrier testing to distribution simulations and package integrity and strength and material characterization testing. DDL offers quick turnaround time, accurate reports and excellent customer service. Our new facility in Fountain Valley, Calif., also includes a design center to help you with rapid time to market for package design. To better serve you, DDL also has labs located in Minnesota and New Jersey.

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: As part of the Moog Medical Devices Group, Ethox's commitment to the advancement of technology in the medical market, paired with an excellent reputation for business integrity, allows us to offer a broad scope of services and solutions to our customers. Capabilities cover the entire lifecycle from design, development and prototyping to fully validated production processes and products. Our offerings include 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. For a complete list of products or services, and for additional company information, visit us at www.ethoxint.com.

Geneva Laboratories Inc

P.O. Box 140

Elkhorn, W153121

Phone: [phone]

Fax: [phone]

Web: www.genevalabs.com

E-mail: [e-mail]

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 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

122 Fairfield Road

Fairfield, NJ 07004

Phone: [phone]

Fax: [phone]

Web: www.gibraltarlabsinc.com

Contact: Dr. Daniel Prince

Services: 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, VDmax, wound care and antimicrobial device research including drug-resistant bacteria, identification of microorganisms, virology, human and adventitous agents, cytotoxicity 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, FITR and methods validation.

Glenbrook Technologies

11 Emery Avenue

Randolph, NJ 07869

Phone: [phone]

Fax: [phone]

Web: www.glenbrooktech.com

E-mail: [e-mail]

Contact: Gil Zweig

Products and Equipment: X-ray Magnification Fluorosopes for inspection and dynamic recording of medical device structure and motion.

Services: Laboratory X-ray services available at an hourly rate.

Comments: Systems that can X-ray and video record actual deployment of stents.

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 include sharpening, pointing, electrochemical edge enhancement, electrochemical deburring, stamping/machining/heat treating, 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 IncisionLab.

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.

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: The MSI catheter & stent testing tools have an emphasis on improving repeatability while increasing accuracy and resolution. Current products include Interventional Device Testing Equipment (IDTE2000) for quantitatively analyzing catheter performance features and Radial Expansion Force Testing Equipment (RX550/650) for testing stent radial strength and stiffness.

Services: Contract catheter tests include track, push, insertion force and torque testing. Contract stent tests include stent radial stiffness, radial strength and hoop force. The IDTE was designed with several international testing standards in mind. These include: ASTM F2394-07 for preconditioning of the stent on the deployment system prior to retention testing, ISO Standard 25539-1:2003(E) Titled" Cardiovascular Implants--Endovascular Devices" and ISO/TS15539:2000(E) Titled" Cardiovascular Implants Endovascular Prostheses." The RX equipment was designed with international testing recommendations in mind. These include: the DA guidance document titled "Non-Clinical Tests and recommended Labeling for Intravascular Stents and associated Delivery Systems", ISO Standard 255391 2003(e) Titled "Cardiovascular implants-Endovascular Devices" and in ISO/TS 15539:2000(E) titled "Cardiovascular Implants--Endovascular Prostheses."

Comments: Machine Solutions Inc. and PROTOMED SA have entered into an exclusive partnership agreement in 2009 to provide product testing services at PROTOMED SA's testing laboratory located in Marseille, France utilizing MSI Interventional Device Testing Equipment and Radial Expansion Force Testing Equipment.

Mark-10 Corp.

11 Dixon Avenue

Copiague, NY 11726

Phone: (888) MARK--TEN

Fax: [phone]

Web: www.mark-10.com

E-mail: [e-mail]

Contact: Mark Fridman

Products and Equipment: Force and torque gauges, test stands, grips, software and accessories.

Medical Device Safety Service GmbH (MDSS)

Schiffgraben 41, 30175

Hannover, Germany

Phone: [phone]

Fax: [phone]

Web: www.mdss.com

E-mail: [e-mail]

Contact: Julia Warnemann

Services: Authorized representative service, external safety officer, vigilance management, quality and risk management, preparation of technical documentation.

Comments: MDSS specializes in European regulatory affairs and acts on behalf of its client as" authorized representative" as it is required by the European CE marking regulations. The service includes product registration, incident and recall reporting, labeling and technical file consulting. MDSS interacts with the commission, the national authorities and distributors.

Minnetronix

1635 Energy Park Drive

St. Paul, MN 55108

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Contact: Dirk Smith

Comments: Minnetronix is a medical device outsourcing company, specializing in the design, manufacturing and support of electronics-based medical devices. Minnetronix's experienced team provides expertise on equipment such as cardiovascular systems, point-of-care diagnostic instruments, therapeutic devices, implantable devices, and monitoring equipment. Minnetronix is ISO 13485:2003certified and is an FDA-registered contract manufacturer.

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 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: [phone]

Fax: [phone]

Web: www.nelsonlabs.com

E-mail: [e-mail]

Contact: Brandon Tillman

Services: 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, reuseable device studies and environmental monitoring. Without our 62,000-square-foot facility, we maintain 80 specialty labs, a custom-built 3,000-square-foot sterility testing cleanroom suite. Nelson employs 320-plus staff members, including more than 130 degreed scientists among whom are 50-plus registered and specialist microbiologists (NRM).

Nitinol Devices & Components

47621 Westinhouse Drive

Fremont, CA 94539

Phone: [phone]

Fax: [phone]

Web: www.nitinol.com

E-mail: [e-mail]

Contact: David Niedermaier

Products and Equipment: From material supply to component fabrication, and device design to testing, analysis, simulation and regulatory support, NDC is the world's most complete provider of Nitinol material and services. Now a completely independent and privately held company, NDC is the medical device industry's partner of choice for Nitinol innovation.

Raven Labs

8607 Park Drive

P.O. Box 27261

Omaha, NE 68127

Phone: [phone]

Fax: [phone]

Web: www.ravenlabs.com

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, a division of Mesa Laboratories, Inc., offers specialty biological indicator and PCD development, D-value testing of inoculated pharmaceuticals and medical devices in Steam, vapor [H.sub.2][O.sub.2], EtO and dry heat. Autoclave cycle validation, heat penetration studies (thermocouple or data logger) and third party confirmation of BI label claims are also available.

Technical Services for Electronics, Inc

108 5th Avenue, NW

Arlington, MN 55307

Phone: [phone]

Fax: [phone]

Web: www.tseinc.net

E-mail: [e-mail]

Contact: Bonnie Suedbeck

Products and Equipment: Electronic cable assemblies, custom connectors.

Services: Clean room assembly, prototype connectors and cable assemblies validation testing (flex, pull test, chemical)

Comments: Technical Services for Electronics provides custom cable assemblies specializing in wire, cable and connectors for medical electronics. TSE's services include contract design manufacturing, packaging and cleanroom assembly. TSE maintains ISO 13485:2003 and ISO 9001:2000.

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 nonporous products or packages, custom test fixtures.

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

WuXi AppTec

2540 Executive Drive

St. Paul, MN 55120

Phone: [phone]

Fax: [phone]

Web: www.wuxiapptec.com

E-mail: [e-mail]

Contact: Dean Enrooth

Services: WuXi AppTec's ISO-certified, FDA-registered 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; and specialized testing for combination/convergent-technology products. In addition, WuXiAppTec's single-source platform features cGMP manufacturing services/aseptic processing for specialty device, combination and tissue-based products. WuXi AppTec also offers GLP/GMP-compliant testing services and contract manufacturing for pharmaceuticals and biopharmaceuticals/cellular therapeutics.