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Quality Management Solution

November 19, 2014 8:48 am | by TIP Technologies | Product Releases | Comments

TIPQA™ is a simple, flexible, yet complete solution for manufacturers who view quality as a competitive advantage. TIPQA™ is optimized for the Aerospace & Defense Industry, Medical Device Industry, and complex manufacturing markets. Use of the TIPQA™ solution has resulted in proven, documented success by countless companies that demand delivery of highly regulated, quality products. TIPQA™...

LISTED UNDER: Product-Safety/Performance Testing

Medtech Design and Testing Services

August 26, 2014 8:30 am | by MDT Staff | Norman Noble, Inc. | Product Releases | Comments

Medical device contract manufacturer Norman Noble, Inc. today announced it has begun providing additional design and testing services to its medtech customers. The expansion...

LISTED UNDER: Component Testing | Medical Device Testing | Other Testing Services

Validation, Testing, and Regulatory Consulting Services

June 17, 2014 12:39 am | by MDT Staff | Nelson Laboratories, Inc. | Product Releases | Comments

Nelson Laboratories announced the expansion of its services with the addition of a dedicated Technical Consulting Services group for MedTech companies. Technical Consulting Services encompasses product development...

LISTED UNDER: Regulatory Affairs | Biocompatibility Testing | Clinical Testing
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Wireless ELF 2 System

December 3, 2013 11:40 am | Tekscan, Inc. | Products

The Wireless ELF 2 System is a user-friendly, cost-effective load measurement system. This system combines 3 FlexiForce WB201 sensors, battery-operated WiFi transmitter (certified 802.11b radio- 802.11b/g/n compatible), and Windows-compatible software*, turning your PC or laptop into a force measurement instrument. The WELF2 system, sampling rates up to 200 Hz, also comes in a high speed version with sampling rates up to 6,000 Hz . The WiFi connection setup has ad hoc and access point (unsecured router) network capability.

LISTED UNDER: Measurement Instruments | Sensors | Product-Safety/Performance Testing

IVD Antimicrobial Testing Services

November 14, 2013 3:15 pm | ATS Labs | Products

ATS Labs helps the developers and manufacturers of antimicrobial impregnated products, such as IVD and others to support their product label claims. ATS Labs proactively assists medical device companies in the development of testing protocols, followed by generation of the necessary efficacy data to support the antimicrobial claims and the FDA regulatory clearance.

LISTED UNDER: Material Testing | Medical Device Testing | Microbiology/Chemical Testing

Cleaning Validation for Point-of-Care Device

November 14, 2013 2:14 pm | ATS Labs | Products

ATS Labs has unmatched experience in assisting clients with the development of custom cleaning and disinfection test protocols for POC devices that have been reviewed by the FDA. ATS Labs is a leader in virucidal efficacy validation of disinfection procedures for BGMS, lancing devices and other POC devices. We welcome the opportunity to work with clients to design a custom, practical validation studies that simulate your process and assures your process is sufficiently robust to protect the users of your products. Contact us to discuss your point of care cleaning and disinfection validation testing needs.

LISTED UNDER: Functional Testing | Material Testing | Medical Device Testing

Reusable Medical Device Cleaning Validation

November 14, 2013 2:09 pm | ATS Labs | Products

ATS Labs performs reusable medical device cleaning validations using quantitative methods that recover clinically relevant soil markers such as hemoglobin, carbohydrates, and protein. The methods used by ATS Labs follow current recommendations in AAMI TIR 30, AAMI TIR 12, and the FDA draft guidance for Processing/Reprocessing Medical Devices in Health Care Settings.

LISTED UNDER: Functional Testing | Medical Device Testing | Microbiology/Chemical Testing

Functional Test and Boundary Scan Development at MD&M Minneapolis

October 28, 2013 10:01 am | by MDT Staff | Product Releases | Comments

ACD will exhibit in Booth #2040 at the upcoming Medical Design & Manufacturing (MD&M) Minneapolis Exposition, scheduled to take place October 29-30, 2013 at the Minneapolis Convention Center.

LISTED UNDER: Other Testing Services
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Mobile iPad Application

October 8, 2013 5:01 pm | by MDT Staff | Product Releases | Comments

Fluke Biomedical announced the launch of its first-ever mobile iPad application. Designed with field service professionals in mind, the app is simple to use and offers detailed product information for all biomedical, diagnostic imaging, radiation, and nuclear power products.

LISTED UNDER: Other Testing Services | Product-Safety/Performance Testing

Laboratory Testing Inc. Offers New Radiography Capabilities

June 18, 2013 5:00 pm | by MDT Staff | Product Releases | Comments

Laboratory Testing has announced the expansion of services available for X-ray inspection, also called radiography or radiographic testing. The laboratory’s Nondestructive Testing Department now performs computed radiography with a Carestream Industrex HPX-1 Digital System, in addition to conventional film radiography.

LISTED UNDER: Laboratory Testing

MED-5440: TRANSLUCENT FLUOROSILICONE ELASTOMER FOR MEDICAL IMPLANT APPLICATIONS

April 29, 2013 10:52 am | NuSil Technology | Products

Carpinteria, California — NuSil Technology LLC, a global leader in silicone materials for the healthcare, pharmaceutical and drug delivery industries, introduces MED-5440, a medical-grade 100 mol % fluorosilicone elastomer that resists swell caused by dimethyl fluids and most solvents or oils. In addition, this product offers the following: rapid cure with heat; compatibility with liquid injection molding equipment; wide range of application feasibility; and translucent appearance. Some typical applications for MED-5440 include O-rings, gaskets, seals, and precision molded parts for implant applications requiring silicones of medium durometers that resist swell.

LISTED UNDER: Silicone | Biocompatibility Testing

MED-9050: SILICONE GEL WITH UNIQUE GREASE-LIKE PROPERTIES

April 29, 2013 10:48 am | NuSil Technology | Products

Carpinteria, California — NuSil Technology LLC, a global leader in silicone materials for the healthcare, pharmaceutical and drug delivery industries, unveils MED-9050, a high-viscosity, crosslinked silicone gel blend designed to be used primarily as a formulary ingredient for topical applications. Its unique, grease-like properties make it ideal for skin care and scar management therapies. MED-9050 is designated as “restricted” and may be considered for use in external devices or short-term implant applications of 29 days or less.

LISTED UNDER: Silicone | Biocompatibility Testing

MED-6731: HIGH-CONSISTENCY FLUOROSILICONE GREASE

April 29, 2013 10:40 am | NuSil Technology | Products

Carpinteria, California— NuSil Technology LLC, a global leader in silicone materials for the healthcare, pharmaceutical and drug delivery industries, introduces MED-6731, a low-flow, high-consistency fluorosilicone grease that resists swell. As a lubricant, MED-6731 will not absorb into or swell dimethyl silicone components. A fluorosilicone fluid may be used for applications in which dimethylpolysiloxane grease has compatibility issues with silicone rubber components. MED-6731 provides an added benefit where migration is a concern. This solvent-resistant grease may be used as a high-vacuum grease around glass, ceramic and ground glass joints.

LISTED UNDER: Silicone | Biocompatibility Testing

VERSASIL LINE: THREE NEW DUROMETERS ADDED

April 26, 2013 5:59 pm | NuSil Technology | Products

Carpinteria, California — NuSil Technology LLC, a global leader in silicone materials for the healthcare, pharmaceutical and drug delivery industries, adds three new products to the VersaSil line, which is now a series of six high-consistency elastomers designed for optimal performance in a wide range of healthcare applications. Featuring high tear strength; wide processing parameters; and translucent, non-tacky surfaces, the new additions are available in unvulcanized base stock that can be cured through either a peroxide catalyst or platinum-cure masterbatch. The base stock, available in 25- or 1,000-pound kits, produces tough, durable elastomers with nominal Type A durometers of 40, 60 and 80.

LISTED UNDER: Silicone | Biocompatibility Testing

MED-6671: LOW COEFFICIENT OF FRICTION SILICONE COATING FOR HEALTHCARE APPLICATIONS

April 26, 2013 5:19 pm | NuSil Technology | Products

Carpinteria, California — NuSil Technology LLC, a global leader in silicone materials for the healthcare, pharmaceutical and drug delivery industries, announces the release of MED-6671, a room temperature curable coating that significantly decreases the coefficient of friction of cured silicone surfaces. Silicone elastomers inherently have a tendency for blocking (sticking to themselves by virtue of chemical affinity). Once cured, MED-6671 chemically bonds to the silicone elastomer substrate, mimicking its mechanical properties and covering this surface tack. The result is a smooth finish with a durable, yet flexible coating that resists abrasion from moving, sliding and rubbing parts.

LISTED UNDER: Silicone | Biocompatibility Testing

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