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Medical Device Testing

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

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
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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 The methods used by ATS Labs follow current recommendations in AAMI TIR 30, AAMI TIR 12, and the FDA draft guidance for Processing/Reprocessing Medical Devices in Health Care Settings.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

FDA Grants Clearance for Biomedical Electrical Safety Analyzer

April 24, 2013 4:14 pm | by MDT Staff | Product Releases | Comments

The United States Food and Drug Administration (FDA) announced today it has granted Fluke Biomedical clearance for the new automated, multifunctional ESA615 Electrical Safety Analyzer 510(k). Now, medical device quality and safety professionals can test to the newest safety standards in just minutes, using this all-in-one automated test tool.

LISTED UNDER: Other Testing Instruments | Medical Device Testing

65GP Series Couplings

April 23, 2013 2:05 pm | LinkTech Couplings | Products

65GP Series: These couplings offer 1/2" flow capacity and are manufactured from a high performance glass filled polypropylene. They have full flow, non-valved, smooth internal bore that allows for maximum flow with minimal turbulence. These couplings are extremely durable and are well suited for applications that require chemical resistance. 65GP Series couplings interconnect with and are compatible with many other plastic latch type couplings. View these products in a 3D PDF or detailed CAD.

LISTED UNDER: Connectors | Couplings | Polypropylenes

50GP Series Couplings

April 23, 2013 2:04 pm | LinkTech Couplings | Products

50GP Series: These couplings are manufactured from a high performance glass filled polypropylene. With excellent chemical resistance properties, these couplings are well suited for applications in acid and chemical transfer. View these products in a 3D PDF or detailed CAD.

LISTED UNDER: Connectors | Couplings | Polypropylenes

50BAC Breakaway Series Couplings

April 23, 2013 2:03 pm | LinkTech Couplings | Products

50BAC Couplings feature LinkTech's new patented breakaway technology. They improve safety by allowing users to make a fast and leak free disconnect with a simple pull of the coupling. The 50BAC couplings utilize a new patented design that facilitates two methods of disconnects, they will safely disconnect when pulled or the user can simply depress the thumb-latch. See which new high tech device features our patented couplings on our blog: http://www.linktechcouplings.com/blog/linktech-supports-medical-device-innovation-with-its-new-patented-50bac-series-breakaway-connectors/

LISTED UNDER: Connectors | Couplings | Acetals
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50AC Series Couplings

April 23, 2013 2:00 pm | LinkTech Couplings | Products

50AC Series: These 1/4 flow size couplings are produced in a durable natural Acetal (POM) thermal plastic. They feature a more cost efficient plastic thumb-latch deign. They are available in both valved and non-valved configurations. View these products in a 3D PDF or detailed CAD.

LISTED UNDER: Connectors | Couplings | Acetals

40CB Series Couplings

April 23, 2013 1:53 pm | LinkTech Couplings | Products

40CB Series: Produced in food grade chrome plated brass, these 1/4" flow size couplings are more durable and withstand higher pressures. They are available with internal shut-off valves or straight through. View these products in a 3D PDF or detailed CAD.

LISTED UNDER: Connectors | Couplings | Medical Device Testing

40PP Series Couplings

April 23, 2013 1:51 pm | LinkTech Couplings | Products

40PP Series: These polypropylene couplings are now available in New Legacy Almond and Modern Cool Grey colors. These color combinations allow customers to choose their preferred coupling color improving their device aesthetics. Check out our New Legacy Almond Couplings: http://www.linktechcouplings.com/LinkClick.aspx?fileticket=ouBolcwcXzE%3d&tabid=145

LISTED UNDER: Connectors | Couplings | Polypropylenes

40AC Series Couplings

April 23, 2013 1:45 pm | LinkTech Couplings | Products

40AC Series: These general purpose 1/4" flow size couplings are produced in a durable natural Acetal (POM) thermal plastic. They feature a thumb-latch release which provides a simple on hand operation. View these products in a 3D PDF or detailed CAD.

LISTED UNDER: Connectors | Couplings | Acetals

20CB Series Couplings

April 23, 2013 1:44 pm | LinkTech Couplings | Products

20CB Series: Produced in food grade chrome plated brass, these 1/8" flow size couplings are more durable and withstand higher pressures. They are available with internal shut-off valves or straight through. View these products in a 3D PDF or detailed CAD.

LISTED UNDER: Connectors | Couplings | Medical Device Testing

20PP Series Couplings

April 23, 2013 1:42 pm | LinkTech Couplings | Products

20PP Series: These polypropylene couplings are now available in New Legacy Almond and Modern Cool Grey colors. These color combinations allow customers to choose their preferred coupling color improving their device aesthetics. Check out our New Legacy Almond Couplings: http://www.linktechcouplings.com/LinkClick.aspx?fileticket=ouBolcwcXzE%3d&tabid=145

LISTED UNDER: Connectors | Couplings | Polypropylenes

20AC Series Couplings

April 23, 2013 1:39 pm | LinkTech Couplings | Products

20AC Series: These 1/8" flow size couplings are produced in a durable natural Acetal (POM) thermal plastic. They are resistant to most mild chemicals and are manufactured to be trouble free for many years of service. View these products in a 3D PDF or detailed CAD.

LISTED UNDER: Connectors | Couplings | Acetals

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