• Supplier: CSA Group

    Description: CSA Group offers you global solutions for product testing & certification that help streamline your access to markets in North America and around the world. By choosing to work with CSA Group, you will benefit from our high level of technical expertise that comes from not only testing products

    • Capabilities: Certification / Qualification, Commissioning, Consulting / Training, Evaluation and Analysis, Reliability / Robustness, Testing, Test Fixtures / Equipment, Test Panel / Sample Prep, Witness / Review, Specialty / Other
    • Forms Tested: Components / Parts, Samples / Materials, Products (Machines / Devices), Other
    • Services Offered: Abrasion / Wear Testing, Acoustic / PIND Testing, Chemical Compatibility Testing, Electrical Characteristics Testing, Fire Characteristics / Flammability, Leak / Seal Testing, Mechanical / Structural (Static Load / Stress), Optical Testing, Performance Testing, Physical Properties Testing, Risk
    • Combined Environments / Conditions: Yes

  • Supplier: E-Labs, Inc.

    Description: E-Labs, Inc. is a Full Service Testing Laboratory, offering customers access to state of the art facilities and personnel. E-Labs personnel have over 40 years of hands on testing experience within all testing disciplines for the Aerospace, Automotive, Military, Commercial and the IT industries

    • Capabilities: Certification / Qualification, Commissioning, Comparisons, Consulting / Training, Engineering Verification Testing, Evaluation and Analysis, Failure Analysis / Troubleshooting, First Article / Contract QA, In-Process In-Line Testing, Proficiency Testing, Reliability / Robustness, Research
    • Forms Tested: Components / Parts, Samples / Materials, Products (Machines / Devices)
    • Services Offered: Abrasion / Wear Testing, Acoustic / PIND Testing, Aging / Life Testing, Chemical Compatibility Testing, Condition Monitoring, Color / Appearance, Dimensional Gaging, Dynamics / Vibration & Shock, Electrical Characteristics Testing, Fire Characteristics / Flammability, Flow / Pressure
    • Combined Environments / Conditions: Yes

  • Description: The MTS Metrology laboratory provides in-house calibration services for a variety of your test and measuring equipment. We also provide technical assistance and customized calibration support to meet your test and measurement requirements.

    • Capabilities: Consulting / Training, Reliability / Robustness, Testing, Test Fixtures / Equipment
    • Services Offered: Mechanical / Structural (Static Load / Stress), Performance Testing, Product Safety / Liability Testing
    • Test / Certify To: FDA
    • Industry Applications: Aerospace / Avionics, Automotive, Building & Construction, Coatings / Paint, Paper / Plastic Packaging, Rubber Products

  • Supplier: F2Labs

    Description: No Description Provided

    • Capabilities: Certification / Qualification, Consulting / Training, Engineering Verification Testing, Evaluation and Analysis, Failure Analysis / Troubleshooting, First Article / Contract QA, In-Process In-Line Testing, Testing, Test Panel / Sample Prep, Witness / Review
    • Forms Tested: Components / Parts, Samples / Materials, Products (Machines / Devices), Capital Equipment
    • Services Offered: Electrical Characteristics Testing, Fire Characteristics / Flammability, Flow / Pressure Testing, Functional / ATE, Leak / Seal Testing, Performance Testing, Risk Assessment, Product Safety / Liability Testing
    • Test / Certify To: CB Report, FDA, IEC, IEEE, MIL-SPEC, NRTL Mark (UL, CSA, TUV, etc.), NSF Standard Mark

  • Description: Development Services. Resolution engineers have over 30 years of experience integrating software and mechanical technologies. Our backgrounds give us great depth in communications, data management systems, mechanical analysis, and testing. Our experience gives us the know how to make the difficult

    • Capabilities: Certification / Qualification, Commissioning, Comparisons, Consulting / Training, Engineering Verification Testing, Evaluation and Analysis, Failure Analysis / Troubleshooting, First Article / Contract QA, In-Process In-Line Testing, Proficiency Testing, Reliability / Robustness, Research
    • Forms Tested: Components / Parts, Samples / Materials, Products (Machines / Devices), Capital Equipment
    • Services Offered: Dimensional Gaging, Optical Testing, Performance Testing, Physical Properties Testing, Risk Assessment
    • Test / Certify To: FDA, OEM Specific

  • Description: Physical testing is essential to measuring the quality and safety of your company's products. ARDL offers a wide range of mechanical testing services to evaluate and certify your materials or components. We have the expertise and resources you need to not only test to universal specifications

    • Capabilities: Certification / Qualification, Comparisons, Consulting / Training, Engineering Verification Testing, Evaluation and Analysis, Failure Analysis / Troubleshooting, In-Process In-Line Testing, Reliability / Robustness, Research and Development, Testing
    • Forms Tested: Components / Parts, Samples / Materials, Products (Machines / Devices)
    • Services Offered: Abrasion / Wear Testing, Aging / Life Testing, Chemical Compatibility Testing, Climatics / Environmental Exposure, Dynamics / Vibration & Shock, Fire Characteristics / Flammability, Flow / Pressure Testing, Leak / Seal Testing, Mechanical / Structural (Static Load / Stress), Optical
    • Test / Certify To: AAMI, ASTM, FDA, MIL-SPEC, OEM Specific, NRTL Mark (UL, CSA, TUV, etc.)

  • Description: Accutek's mechanical testing qualifications include: - Tensile (ounces to 60,000+ lbs) - Fatigue (axial, bending, torsion, roller chain) - Rotating Beam - Charpy Impact (NIST Certified) - Hardness (micro to Brinell, including Shore A) - Abrasion (Taber, micro-motion, porous coating) - Torque

    • Capabilities: Certification / Qualification, Comparisons, Evaluation and Analysis, Failure Analysis / Troubleshooting, In-Process In-Line Testing, Reliability / Robustness, Research and Development, Testing, Test Fixtures / Equipment, Test Panel / Sample Prep, Specialty / Other
    • Forms Tested: Components / Parts, Samples / Materials, Products (Machines / Devices), Other
    • Services Offered: Abrasion / Wear Testing, Aging / Life Testing, Chemical Compatibility Testing, Dimensional Gaging, Flow / Pressure Testing, Leak / Seal Testing, Mechanical / Structural (Static Load / Stress), Performance Testing, Physical Properties Testing, Product Safety / Liability Testing, Specialty / Other
    • Combined Environments / Conditions: Yes

  • Description: TÜVRheinland® delivers premier independent testing, assessment, and certification services to help companies gain access into global markets. Boasting an international network across six continents, the company's in-country experts ease the path to compliance with cost-effective pricing and quick

    • Capabilities: Certification / Qualification, Commissioning, Comparisons, Consulting / Training, Engineering Verification Testing, Evaluation and Analysis, Failure Analysis / Troubleshooting, First Article / Contract QA, In-Process In-Line Testing, Proficiency Testing, Research and Development, Testing, Test
    • Forms Tested: Components / Parts, Samples / Materials, Products (Machines / Devices), Capital Equipment
    • Services Offered: Abrasion / Wear Testing, Acoustic / PIND Testing, Chemical Compatibility Testing, Dimensional Gaging, Dynamics / Vibration & Shock, Electrical Characteristics Testing, Functional / ATE, Leak / Seal Testing, Mechanical / Structural (Static Load / Stress), NDT / Inspection, Performance
    • Test / Certify To: AAMI, ASTM, CB Report, FDA, IEC, IEEE, MIL-SPEC, NIST, OEM Specific, NRTL Mark (UL, CSA, TUV, etc.), NSF Standard Mark, Other

  • Description: TÜVRheinland® delivers premier independent testing, assessment, and certification services to help companies gain access into global markets. Boasting an international network across six continents, the company's in-country experts ease the path to compliance with cost-effective pricing and quick

    • Capabilities: Auditing / Assessment, Certification, Consulting / Training, Field Evaluation / On-site Inspection, In-process / In-line Testing, Qualification / Commissioning, Pre-assessment / Gap Analysis, Program Development (QA Manual / Procedures), Registration, Testing, Specialty / Other
    • Certification Level: Components / Parts, Facilities / Equipment, Products (Equipment / Devices), Quality / Management Systems, Services
    • Certify / Evaluate To: AAMI, ASTM, FCC (US), FDA, CB Report, CCC (China), CE Mark (Europe), CSA Mark, C-TICK (Australia & New Zealand), Gost R (Russia), GS Mark, IEC, IEEE, InMetro (Brazil), ISO, ISO 9001:2000, ISO 13485/8, ISO 14001, ISO 14644, ISO/TS 16949:2002 , ISO 17020, ISO 17025, NOM (Mexico), UL / ETL
    • Industry Applications: Appliances, Aerospace / Avionics, Automotive, Building Products, Combustion Equipment, Electrical Distribution, Hazardous Location Equipment, Health Care / Medical, Industrial / Machinery, Materials, Piping / Pressure Vessels, RF / Wireless Products, Semiconductors / IC Packages, Welding

  • Description: MANAGEMENT SYSTEMS CERTIFICATION Bureau Veritas Certification is one of the world's leading certification bodies, providing a comprehensive range of management system certification and training services from internationally-recognized standards to more customized schemes, in the fields of Quality,

    • Capabilities: Auditing / Assessment, Certification, Consulting / Training, Field Evaluation / On-site Inspection, In-process / In-line Testing, Qualification / Commissioning, Pre-assessment / Gap Analysis, Program Development (QA Manual / Procedures), Registration, Testing, Witness / Review, Specialty
    • Certification Level: Components / Parts, Facilities / Equipment, Products (Equipment / Devices), Quality / Management Systems, Samples / Materials, Services
    • Certify / Evaluate To: ASTM, FCC (US), FDA, CE Mark (Europe), Gost R (Russia), IEC, ISO, ISO 9001:2000, ISO 13485/8, ISO 14001, ISO 14644, ISO/TS 16949:2002 , ISO 17020, ISO 17025, OEM Specific, OHSAS 18001, RC 14001, RoHS, SA 8000, S Mark, TL 9000, Other
    • Industry Applications: Appliances, Aerospace / Avionics, Automotive, Building Products, Battery / Energy Products, Cleanrooms, Combustion Equipment, Coatings / Paint, Food / Drugs, Electrical Distribution, Electronics, Food & Beverage, Hazardous Location Equipment, Health Care / Medical, HVAC, Industrial /

  • Description: USE OF INTERNATIONAL STANDARD ISO-10993, "BIOLOGICAL EVALUATION OF MEDICAL DEVICES PART 1: EVALUATION AND TESTING"

  • Supplier: Restek

    Description: Meet new FDA Guidance for Industry: Testing of Glycerin for Diethylene Glycol with our new diethylene glycol (DEG) and ethylene glycol limit standards. This Guidance emphasizes the importance of screening raw material for the presence of diethylene glycol. Under cGMPs, drug manufacturers&mdash

    • Form: Liquids

  • Description: Clear Dome Bags are made of PVC that is 100 gauge thick. To shrink, apply hot air using heat gun or household blow-dryer. Material does not emit foul odor. SGS testing certifies compliance with FDA and ROHS standards.

    • Type: Bag / Sack
    • Materials: Plastic, PVC

  • Description: after clinical use. The method consists of two parts: a Simulated Donning Test Procedure and a Shaker Table Abrasion Procedure. FDA water leak testing was performed to detect defects after stressing the gloves. In the donning procedure, a donning apparatus is used to simulate the stresses of donning

  • Description: environmental rooms and incubators are designed to meet FDA and ICH guidelines for stability testing and storage. They're installed in facilities around the world where technicians can reach-in, walk-in or even drive-in to conduct a wide variety of simulation testing. We use the highest quality

    • Type: Environmental Stability, Plant Growth
    • Configuration: Laboratory / Room
    • Test Parameters: Temperature, Humidity
    • Temperature Control: Heating, Cooling

  • Supplier: Aralab

    Description: FitoClima 600 & 1200 Pharma Reach-in Chambers for Stability and Photostability Testing ICH, GMP, WHO, FDA Compliant Climatic Chambers with 600 or 1200 liters of internal volume, designed for Stability and Photostability tests on pharmaceutical products according to ICH guidelines Q1A and Q1B

    • Application: Solar Simulators and Light Sources, Other
    • Configuration: Chamber
    • Spectral Range: Visible / UVV
    • Lamp Intensity: 3.00E-4 to 0.0030 W/cm²

  • Supplier: Aralab

    Description: FitoClima 600 & 1200 Pharma Reach-in Chambers for Stability and Photostability Testing ICH, GMP, WHO, FDA Compliant Climatic Chambers with 600 or 1200 liters of internal volume, designed for Stability and Photostability tests on pharmaceutical products according to ICH guidelines Q1A and Q1B

    • Configuration: Reach-In
    • Chamber Capacity: 159 gallons
    • Test Parameters: Temperature, Humidity
    • Temperature Control: Heating, Cooling

  • Description: Low volatile grade, platinum-cured silicone hose produced in a clean room for critical pharmaceutical, biomedical, cosmetic, and food applications. Polyester yarn braiding inside the wall enhances the pressure capabilities. APSH has undergone extensive physical, chemical, and biological testing

    • Product Form: Hose (including Duct)
    • Inside Diameter: 0.1880 inch
    • Outside Diameter: 0.4620 inch
    • Working Pressure: 170 psi

  • Description: Low volatile grade, platinum-cured silicone tubing produced in a clean room for critical pharmaceutical, biomedical, cosmetic, and food applications. APST has been put through extensive physical, chemical, and biological testing, and meets USP Class VI, FDA CFR 177.2600, ISO 10993, NSF 51, European

    • Material Choices: Rubber / Silicone / Elastomer Tubing
    • Design Units: English, Metric
    • Outside Diameter / Size: 0.2500 inch
    • Maximum Inside Diameter / Size: 0.1250 inch

  • Description: Berry Plastics Tapes and Coatings Division FIBC Division produces an extensive line of Flexible Intermediate Bulk Containers (FIBCs) to meet both large and small volume requirements. Our bags are manufactured from FDA approved materials in a durable woven polypropylene construction with custom

    • Type: Bag / Sack
    • Materials: Polypropylene (PP)

  • Description: . The material is physiologically harmless and FDA compliant. Tecaform™ AH MT is used to make instrument handles, and for prosthesis part testing. Made with Celcon® Strength, Rigidity Good sliding properties Heat resistant Good Electrical insulation Easily welded Easily machined Available

    • Chemical / Polymer System Type: Acetal
    • Form / Shape: Rod / Round Stock
    • Overall Width / O.D.: 1 to 3.5 inch
    • Overall Length: 48 to 96 inch

  • Description: METTLER TOLEDO's highly sensitive dissolved oxygen (DO) sensors are specifically designed for demanding low DO concentration applications. The InPro 6900 series sensors for F&B application are made of FDA compliant materials and have a highly polished surface finish to facilitate cleaning

    • Water Quality Measurement Instrument: Dissolved O2
    • Mounting / Environment: Other
    • Temperature Compensation: Yes
    • Display Type: None

  • Description: Definitive Dialysate Testing The Myron L D-4 is specifically designed to test both acetate and bicarbonate dialysate quality. Measure Conductivity, pH and Temperature to ensure proper mixing during dialysate preparation and as a final check of dialysate quality before hemodialysis treatment

    • Mounting / Environment: Portable, In-Situ / Field

  • Description: Dialysate Meter has received FDA 510(k) acceptance for use as a medical device for testing dialysate. Range of readings Conductivity: 0-9999 S/cm, 10-200 mS/cm NaCl in 5 autoranges Resistivity: 10 KΩ-30 MΩ NaCl TDS: 0-9999 ppm/10-200 ppt 442 in 5 autoranges pH: 0-14 pH ORP/Free Chlorine

    • Measures Conductivity / Dissolved Solids: Yes
    • Conductivity / Dissolved Solids Range: 10 to 200 µS/cm
    • Mounting / Environment: Portable, In-Situ / Field

  • Description: , shows a charge decay time constant of < 1 second, based on independent lab testing. Food Grade Materials - Hose tube complies with FDA(05) requirements. Grounding wire embedded in external helix to prevent material contamination. Extra Thick Abrasion Resistant Double-Ply Polyurethane Tube

    • Product Form: Hose (including Duct)
    • Inside Diameter: 2 to 8 inch
    • Outside Diameter: 2.67 to 9.25 inch
    • Working Pressure: 25 to 40 psi

  • Description: -Good heat resistance -Self extinguishing -Nonwetting Certifications -AMS-DTL-23053/11, Class 1 -ASTM D2902 Type II -ASTM D3296-98 -FDA Compliant -USP Class VI Compliant Applications -Protective Cover -UV Light Covering -Product Testing -Rollers

    • Sleeving: Shrink Tubing
    • Material: Other
    • Diameter: 0.6660 inch
    • Length: 48 inch

  • Description: Cambridge Polymer Group can aid in many areas of process development, from initial R&D and formulation, through regulatory testing, product support and marketing and failure analysis. If your product is not meeting requirements, we can help you reformulate to match specific properties and determine

    • Services Offered: Analytical Testing / Inspection, Process Development, Process Optimization, Research and Development, Technology and Licensing, Training / Consulting, Specialty / Other
    • Form: Bulk Solids / Granules, Liquids, Nanomaterials / Nanoparticles, Powders
    • Chemicals / Chemical Products: Alcohols, Chemical Agents / Additives, Cleaners / Surface Active Agents, Cosmetics / Soaps, Filler / Extenders, Inorganic Chemicals, Lubricants / Greases, Monomers and Intermediates, Oils and Fuels, Organic Chemicals, Pharmaceuticals / Drugs, Pigments / Dyes, Polymers, Reagents, Solvents
    • Materials / Material Products: Abrasives, Adhesives / Sealants, Coatings / Paint, Elastomers / Rubber, Foods / Beverages, Plastics, Pulp and Paper, Wafers / Semiconductor Materials, Textiles, Wood Products

  • Description: ) makes it suitable for vacuum applications down to 3×10-2 mm Hg at 165 °F (74 °C). Ideal for analytical testing of gases or vapors. Well-suited for use in making manometers. Holds full vacuum at room temperature Will not crack and age like rubber tubing Excellent clarity for visual

    • Material Choices: Plastic Tubing
    • Shape: Round
    • Finish: Clear
    • Application: Pneumatic (Vacuum)

  • Description: electronics, mechanics and optics to produce unique and specialized equipment. The majorityof TRICOR's products have been developed for testing and quality assurance functions in themilitary, switch, food and light measurement industries. Expertise also includes electronic contract manufacturing

    • Services: Certification and Compliance, Design Support, Electrical Design, Electronic Design, Embedded System Design, Industrial Design, Product Design, Software Development, Systems Design, Testing
    • Industry Served: Aerospace, Electronics, Food and Beverage, General Industrial, Medical, Military
    • Location: North America, United States Only, Midwest US Only

  • Description: ON-SITE STABILITY STORAGE ROOMS FOR PHARMACEUTICAL COMPANIES Each Parameter pharmaceutical room is custom built to meet ICH and FDA guidelines for storage conditions for pharmaceutical products. Our rooms are used by many drug companies for active substances stability studies, stress testing

    • Type: Environmental Stability
    • Configuration: Walk-In
    • Test Parameters: Temperature, Humidity
    • Temperature Control: Heating, Cooling

  • Description: : •FDA-approved surfaces for efficient clean-down •Containment tank for proper disposal of wastewater •Positive pressure air controls with HEPA filtered air •Dedicated laboratory for product quality testing •Secure facility with limited access •Shatterproof glass

    • Services Offered: Analytical Testing / Validation, Contract Manufacturing, Process Optimization / Development, Research and Development, Trial Facility Leasing / Tolling, Warehousing / Distribution
    • Run / Batch Size: Laboratory / Benchtop Scale, Pilot Scale, Production Lots / Field Scale
    • Form: Bulk Solids / Granules
    • Chemicals: Biochemicals / APIs, Chemical Agents / Additives, Inorganic Chemicals, Organic Chemicals, Pigments / Dyes, Specialty / Other

  • Description: to ensure uniform storage and testing conditions. The OM-CP-ULT90 includes a USB docking station with 1.8 m (6') of cable (OM-CP-IFC300), the OM-CP-CRYO-TEMP data logger, and FDA 21 CFR Part 11 Secure Software and IQ/OQ/PQ validation protocols. For larger freezers, loggers can be plotted in one graph

    • Sensed Temperature Range: -121 to 131 F
    • Input Options: Permanent Sensor or Probe
    • # of Inputs / Channels: 9 to 15 #
    • Local Interface: Analog Front Panel

  • Description: complies with FDA 177.2600 criteria, 3A Sanitary Standards and NSF Standard 51, which are applicable to many food contact applications. Norprene® Pressure Tubing exhibits excellent resistance to ozone and UV light, with little or no signs of deterioration in laboratory testing equivalent to 10 years

    • Material Choices: Plastic Tubing, Rubber / Silicone / Elastomer Tubing
    • Design Units: English
    • Outside Diameter / Size: 0.8750 inch
    • Maximum Inside Diameter / Size: 0.6250 inch

  • Description: The Phantom Pharmaceutical metal detector provides the ideal solution for detection and rejection of the smallest contaminants in tablets and capsules. With its current GMP design and construction suited for FDA compliance, the system meets the stringent QA requirements of the pharmaceutical

  • Description: Min. Burst Pressure is 4x Max. Working Pressure - Change in length at working pressure is +2% to -4%. Tube: Natural FDA Compliant PTFE Reinforcement: 304 Stainless Steel Cover: Black Abrasion Resistant Urethane Temperature: -40ËšF to +275ËšF - -40ËšC to +135Ëš

    • Product Form: Hose (including Duct)
    • Maximum Vacuum: 12 in Hg vac
    • Temperature Range: -40 to 275 F
    • Material: Fluoropolymers / Silicone

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Parts by Number for FDA Testing Top

Part # Distributor Manufacturer Product Category Description
GT13L Digi-Key TPI (Test Products Int) Test and Measurement BEADED PROBE WHITE FDA APPROVED
FK22M Digi-Key TPI (Test Products Int) Test and Measurement 100MM STEM FDA INSULATION
GK13M Digi-Key TPI (Test Products Int) Test and Measurement FDA APPROVED INSULATION

Conduct Research Top

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  • Medical Device Link . A 510(k) PRIMER: FDA'S PREMARKET NOTIFICATION PROCESS
    for Testing and Materials (ASTM) standards, or their equivalent, and that they pass FDA's 1000-ml water leak test.24 26 The gloves must also pass the leak test after undergoing accelerated aging according to one of the protocols described by ASTM, or their equivalent.24,25 If the kit contains
  • Will USP and FDA Reach Consensus on Stability Testing?
    tablets are an imperfect solution, and only illustrate the imprecision of stability testing today. As professors Piero Armenante (from New Jersey Institute of Technology) and Fernando Muzzio (of Rutgers) demonstrated in a recent report to FDA, hydrodynamics within testing equipment can cause tremendous
  • Liqui-Cel (R) Membrane Contactors: FDA Toxicity and Extractable Test Summary (.pdf)
    Liqui-Cel (R) Membrane Contactors are used in many diverse applications and markets that require various tests to be completed. FDA Compliance Our Food and Beverage applications require our products to be made with FDA compliant materials. We complete toxicity testing as needed for materials being
  • Combination Products: Navigating Two FDA Quality Systems
    direction and emphasis regarding product safety and FDA requirements. Navigant Consulting estimated the market at $5.9 billion in 2004 and predicted a 10% compound annual growth rate that will see the market reach approximately $9.5 billion in 2009. FDA received 275 combination product submissions
  • Combination Products: Navigating Two FDA Quality Systems
    manufacturers are struggling to address a host of testing guidelines, practices and regulations unique to the development and production of combination products. In addition, FDA regulatory centers are laboring with the changes and challenges that these new technologies present. A device is defined
  • Combination Products: Navigating Two FDA Quality Systems
    . Cell-based therapeutics create unusual challenges for combination product manufacturers and FDA. Characterization of biological source material is a critical requirement for safety considerations. This is due to the inherent variability in the source material. Sterilization of combination products can
  • Janet Woodcock, FDA's Chief Medical Officer, on PAT, QbD and the Critical Path
    and Leading Biotech Manufacturers To Collaborate in Unprecedented Effort of Advancing Application of Quality By Design Paradigm in Biotech Environment FDA, C-Path Create Predictive Safety Testing Consortium Podcast: FDA's Dr. Janet Woodcock on New Directions for FDA in 2007 Achieving Manufacturing

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