|
|
|
|
Welcome to GlobalSpec!
Find parts, products, suppliers, datasheets, and more for:
Fda Evaluation
Find Suppliers by Category
Environmental testing and analytical services provide testing of environmental samples such as soil, water, air, and industrial wastes or byproducts.
Search by Specification |
Learn More
Products & Services
See also: Featured Products | Technical Articles | Engineering Web Results-
Supplier: Real Seal CompanyDescription: Rubber & Plastic Material Engineering Support Real Seal offers complete materials engineering support with a Laboratory and Polymer Chemist on Staff. From specification development through material mix and prototypes, Real Seal has the experience and resource base to help determine the best
- Discipline: Industrial Engineering, Materials Engineering, Mechanical Engineering
- R & D: CAD Design, Industrial Design, Materials Research, Process Design, Product Design
- Testing, Inspection & Certification: Laboratory Testing, Materials Testing, Investigative Studies, Reverse Engineering, Condition Evaluation, FDA / Regulatory Compliance
- Management: Project Management
-
Supplier: Nye Lubricants, Inc.Description: certification and food safety evaluations. In addition to products listed below, Nye can work directly with you to formulate new synthetic lubricants for your food processing and handling equipment, ensuring the new formulations use FDA recognized raw materials. We can also register new
-
Supplier: Product Safety Consulting, Inc.Description: Recognized Testing Laboratories (NRTL), such as Underwriters Laboratories, Intertek/ETL, the Canadian Standards Association (CSA), QPS, SGS, MET Labs, and many others. We understand the additional costs in time and money that are incurred when a product fails an evaluation or test. That is why we
- Discipline: Electrical Engineering, Other Engineering
- R & D: Other R&D
- Testing, Inspection & Certification: Laboratory Testing, Materials Testing, Investigative Studies, Condition Evaluation, Environmental Compliance, FDA / Regulatory Compliance
- Industry Served: Aerospace, Building / Construction, Computer Systems, Electrical / Electronics, Health & Safety, HVAC, Manufacturing, Medical, Network / Communications, Utilities and Energy, Other Market Served
-
Supplier: TÜV SÜD America Inc.Description:
- Certify / Evaluate To: AAMI, FCC (US), FDA, CB Report, CCC (China), CISPR, CSA Mark, C-TICK (Australia & New Zealand), GS Mark, IEC, IEEE, ISO, ISO 9001:2000, ISO 13485/8, ISO 14001, ISO/TS 16949:2002 , ISO 17025, MIL-SPEC, NOM (Mexico), UL / ETL / CSA, OEM Specific, OHSAS 18001, RoHS, S Mark, Telecordia / Bellcore, TL 9000, VCCI (Japan), WEEE, Other
- Capabilities: Auditing / Assessment, Certification, Consulting / Training, Field Evaluation / On-site Inspection, Qualification / Commissioning, Registration, Testing, Witness / Review
- Certification Level: Components / Parts, Products (Equipment / Devices), Quality / Management Systems, Services
- Industry Applications: Appliances, Aerospace / Avionics, Automotive, Battery / Energy Products, Combustion Equipment, Food / Drugs, Electrical Distribution, Electronics, Hazardous Location Equipment, Health Care / Medical, HVAC, Hydraulics / Pneumatics, Industrial / Machinery, Instruments / Sensors, Marine, Motor Controllers / Control Systems, RF / Wireless Products, Semiconductors / IC Packages, Valves / Pumps, Specialty / Other
-
Supplier: Suntron CorporationDescription: innovative solutions tailored to match individual requirements, while meeting the highest quality standards in the industry. Certifications: AS9100 NADCAP cGMP (QSR 21 CFR Part 820) ISO 9001 : 2008 ISO 13485 : 2003 ISO 14001 J-STD-001 IPC-A-610 Class II, III IPC 620A FDA
- Capabilities: Design Assistance, Part Procurement, Prototype / Low Production Quantities, Large Production Quantities, Subsystem Assembly, Full System Assembly (Box Build), Testing and Evaluation, Just-In-Time Capability
- Location: North America, United States Only, Northeast US Only, Southern US Only, Southwest US Only, Other
-
Supplier: TÜV RheinlandDescription: 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
- 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 / CSA, OHSAS 18001, PSE Mark (Japan), RoHS, SA 8000, S Mark, TL 9000, VCCI (Japan), WEEE, Other
- 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
- 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 & Fabrication, Specialty / Other
-
Supplier: Cambridge Polymer Group, Inc.Description: the appropriate analytical tests for evaluation. We can also help to develop quality control methods for many different polymer products from chemical characterization to determine polydispersity to mechanical testing for determining tensile or compressive material properties that are important
- Services Offered: Inspection & Analytical Testing, Process Development Services, Process Optimization, Research and Development, Technology & Licensing, Training / Consulting, Specialty / Other
- Form: Liquids, Powders, Nanomaterials, Bulk Solids / Granules
- Chemicals / Chemical Products: Alcohols, Chemical Agents / Additives, Cleaners / Surface Active Agents, Cosmetics / Soaps, Filler / Extenders, Foods / Beverages, Inorganic Chemicals, Lubricants / Greases, Monomers & Intermediates, Oils & Fuels, Organic Chemicals, Pharmaceuticals / Drugs, Pigments / Dyes, Polymers, Reagents, Solvents
- Materials / Material Products: Abrasives, Adhesives / Sealants, Coatings / Paint, Elastomers / Rubber, Plastics, Pulp & Paper, Semiconductor Materials, Textiles, Wood Products
-
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: Testing / Simulation, Certification / Qualification / Commissioning, Component / Product Comparison, In-process / In-line Testing, Engineering / Design Verification (DVT), Evaluation / Troubleshooting (FMEA), Research and Development, Test Development, Test Fixtures / Equipment, Test Panel / Sample Prep, Specialty / Other
- Forms / Items Tested: Components / Parts, Products, Facilities / Capital Equipment, Samples
- Services: Aging / Life Testing, Altitude Simulation, Decompression / Vacuum, Fatigue / Endurance, Flow Testing, Fungus / Biofouling, Gunfire / Pyrotechnic Shock , Leak / Seal Testing, NDT / Inspection, Pressure / Hydrostatic Testing, Thermal Cycling / Shock, Specialty / Other
- Industry Applications: Appliances, Aerospace / Avionics, Automotive, Building Products, Coatings / Paint, Food / Pharmaceuticals, Combustion Equipment, Hazardous Location Equipment, Health Care / Medical, Hydraulics / Pneumatics, Industrial / Machinery, Marine, Nuclear / Utility, Valves / Pumps, Specialty / Other
-
Supplier: Chemir Analytical ServicesDescription:
- Discipline: Chemical Engineering, Materials Engineering
- R & D: Materials Research, Packaging Design, Scientific Research, Other R&D
- Testing, Inspection & Certification: Laboratory Testing, Materials Testing, Investigative Studies, Reverse Engineering, Condition Evaluation, FDA / Regulatory Compliance
- Facilities: Quality Assurance
-
Supplier: IMR Test LabsDescription:
- Discipline: Chemical Engineering, Electronic Engineering, Environmental Engineering, Materials Engineering, Mechanical Engineering
- R & D: Materials Research
- Testing, Inspection & Certification: Laboratory Testing, Materials Testing, Investigative Studies, Reverse Engineering, Condition Evaluation, FDA / Regulatory Compliance, Other TIC Services
- Industry Served: Aerospace, Automotive, Chemicals, Electrical / Electronics, HVAC, Manufacturing, Marine / Naval, Medical, Oil and Gas, Utilities and Energy
Featured Products for Fda Evaluation Top
-
510(k) Applications. TUV America Inc. is authorized by the FDA under the Accredited Persons program to submit 510(k) applications on behalf of medical device manufacturers for all eligible Class I & II devices. TUV America has been involved in the FDA 510(k) third-party review program since its inception in 1996. Today, TUV offers third-party submission services for over 600 devices. Also known as a premarket notification, a 510(k) submission allows the U.S. Food and Drug Administration... (read more) -
Delmar Company is dedicated to supplying custom FDA approved products. When the standard commodities don't meet your requirements we have a wide variety of FDA, 3A and USP Class V1 approved sealing products to meet your needs. We can supply custom gaskets cut from sheet materials or vulcanized silicone O'rings in any size. Some of our FDA approved products include: Sanitary Gaskets. Sheet Gasketing. Viton, EPDM, Silicone & Teflon. USP Class V1 O'rings and gaskets are available... (read more) -
SRS has 50 years of experience and many proven designs using various engineered plastics to solve a very broad range of seal problems. The applications for these valves and unions range from pharmaceutical with stringent FDA specifications to industrial systems handling acids. Depending on your application, we can engineer, design, source, manufacture, assemble and test rock solid solutions to difficult fluid seal problems. (read more) -
for yourself why we have a national reputation. Around the country or around the clock, we'll come through for you!. National Rubber Corporation, extruded rubber parts, MilSpec, FDA, NSF, UL, AMS, ASTM, Lockheed Specifications... (read more) -
If your product calls for for high quality, complex shapes, or fast turn-around, call the supplier with a national reputation: National Rubber Corporation. Quick turn around and high quality are advantages of National Rubber. We use a proprietary Engineering Data Worksheet to document our quality from product to product, and lot to lot. It helps us to meet MilSpec, FDA, NSF, UL, AMS, ASTM, Lockheed Specifications. All products are having Tolerances per RMA levels. If your product demand custom... (read more) -
For food, pharmaceutical and medical equipment applications. FDA compliant compounds available in food grade white, gray, and black. Widely used for OEM, production and laboratory applications. Inflatable bags, bladders, and plugs also featured. Design assistance offered. (read more) -
Epoxies, Etc. has introduced a new elastomeric Potting and Encapsulating Compound developed for the protection of electronic circuits, components, and devices. This product is formulated to cushion and protect sensitive electronic components. The 20-2121 will impart very little stress on components during cure or thermal cycling. 20-2121 is FDA Compliant. The raw materials used in this product are listed under different FDA CFR 21 Sections which allow these materials to be used in applications... (read more) -
If your product calls for high quality , complex shapes, or fast turn-around, call the supplier with a National reputation: National Rubber Corporation. Quick turn around and high quality are advantages of National Rubber. They use a proprietary Engineering Data Worksheet to document our quality from product to product, and lot to lot. It helps them to meet MilSpec, FDA, NSF, UL, AMS, ASTM, Lockheed specifications. All products are having Tolerances per RMA levels. If your products demand... (read more) -
All-Flo's line of FDA-compliant All-P ũR® pumps are ideal for use in commercial food processing and sanitary applications. Manufactured from corrosion-resistant electropolished and passivated stainless steel with a Tri-Clamp connection, the All-P ũR® pumps come in a range of sizes to fit a variety of applications and are equipped to handle solids. Continually setting the pace for advancement in the diaphragm pump industry, All-Flo also just released its series of aluminum and nitrile... (read more) -
Building on its versatile range of products, All-Flo Pump Company has recently introduced two innovative pump series for use in a broader set of customer applications. A leading manufacturer of diaphragm pumps, All-Flo supplies hundreds of distributors around the world with lube-free, non-stall products. All-Flo recently launched its line of FDA-compliant All-PuR® pumps, ideal for use in commercial food processing and sanitary applications. Manufactured from corrosion-resistant electropolished... (read more)
Conduct Research Top
-
Tracking FDA s Interaction with Industry
By Agnes Shanley, Editor in Chief Last month, BIOCOM and PriceWaterhouseCoopers released Improving America s Health IV, the latest in a series of surveys that focus on FDA s relationship with life sciences companies. This survey received considerable input from FDA officials and directors...
-
FDA Sets Its House in Order
its decisions. It is also redefining that science, in efforts such as the Critical Path initiative. As Dr. Janet Woodcock, FDA s Deputy Commissioner, reiterated at the recent IFPAC conference in Baltimore, The drug development process is becoming a serious bottleneck. We re using the evaluation...
-
FDA May Lead Industry to Water, But Will It Drink?
FDA May Lead Industry to Water, but Will it Drink? The advance billing promised a candid discussion on "what to expect from FDA." But that turned out to be only half the story. Indeed, when Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER) joined a panel...
-
FDA to Prescribe New Drug Manufacturing Standards
concepts, this announcement "lays a public foundation for moving forward in this direction," Richman says. "The focus is shifting from not just what went wrong, but to a higher level evaluation of How healthy is the system?" According to FDA, its compliance programs already are structured "not to pick...
-
How to Respond to (& Avoid) FDA 483s (.pdf)
systems. Worse, with the increase in enforcement staff and the shortening of the response time - now 15 days - the FDA appears to be ramping up its enforcement mandate. Learn how to respond appropriately to the dreaded FDA 483 - and avoid being issued one on GxP deficiencies in monitoring and measuring...
-
FDA's Janet Woodcock on PAT and The Critical Path
the door. The development process is becoming a serious bottleneck. Our theory at FDA, and we ve said this publicly, across the board, is that we re using the evaluation tools and infrastructure of the last century and in some cases, tools from very early in the last century to develop...
-
Upfront: FDA/Conformia Report CRADA Progress
By Agnes Shanley, Editor in Chief FDA and Conformia s CRADA team reports that its next joint workshop on ICH, the first of several that will be held this year, will take place on February 20 and 21 in the D.C. area. The team will receive its 2007 Pharmaceutical Manufacturing Team of the Year award...
-
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...
-
FDA's Pharmaceutical Inspectorate Searches for Higher Ground
and given site assignments by the Office of Regulatory Affairs in the field, the training has been a collaborative effort on the part of ORA, the Center for Drug Evaluation and Research (CDER) including Ajaz Hussein and key members of the Office of Pharmaceutical Science other FDA Centers...
-
FDA's Pharmaceutical Inspectorate Searches for Higher Ground
of ORA, the Center for Drug Evaluation and Research (CDER) including Ajaz Hussein and key members of the Office of Pharmaceutical Science other FDA Centers, industry and academia. In addition, it follows on the heels of stepped up training programs for investigators in medical devices...
Engineering Web Search: Fda Evaluation Top
|
General Principles of Software Validation; Final Guidance for... Follow FDA Subscribe to Emails Enter Search terms General Principles of Software Validation; Final Guidance for Industry and FDA Staff |
|
|
Guidance for Industry and FDA Staff - Total Product Life... Follow FDA Subscribe to Emails Enter Search terms |
|
|
ASTM International - Standards Worldwide See ASTM International Information |
|
|
EVAL-CED1Z Converter Evaluation and Development (CED) Board... color Error : Bad color Error : Bad color Error : Bad color Converter Evaluation and Development (CED) Board Preliminary Technical Data EVAL-CED1Z See Newark / element14 Profile & Catalog |
|
|
FDA: Between Process and Product Evaluation FDA: Between Process and Product Evaluation |
|
|
Safety and Health Topics | Laser Hazards FDA/CDRH Federal Product Performance Standard Evaluation Outline. See Occupational Safety & Health Administration (OSHA) Information |
|
|
A Workshop on Measurement Methods for Evaluation of the... A Workshop on Measurement Methods for Evaluation of the Reliability of Active Implantable Medical Devices October 3?4, 2005 Lecture Room B |
|
|
Welcome To Loftware Enterprise Labeling Solutions Downloads Software Evaluation Upgrades Software Evaluation With Loftware's Design and Print evaluation software, you can try the leading See Loftware, Inc. Information |
|
|
Polyvinyl chloride - Wikipedia, the free encyclopedia |
|
|
Magnetic resonance imaging - Wikipedia, the free encyclopedia In the case of cochlear implants, the US FDA has approved some implants for MRI compatibility. |
More >>
