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Medical Device Test Articles & Analysis

12 news found

STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance

STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance

STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing Services for the development of safe and effective medical ...

BySTEMart


Protheragen-ING Lab, a Trustworthy GLP Service Provider, Unveils Its Cutting-Edge Medical Device Services

Protheragen-ING Lab, a Trustworthy GLP Service Provider, Unveils Its Cutting-Edge Medical Device Services

The new service offerings include medical device safety testing, biocompatibility testing, validation and verification, and reusable medical device testing. ...

ByProtheragen-ING


STEMart Launches New Force Degradation Services to Ensure Drug Stability and Safety

STEMart Launches New Force Degradation Services to Ensure Drug Stability and Safety

STEMart, a US-based provider of comprehensive services for all phases of medical device development, announced the launch of its new Force Degradation Services to help pharmaceutical and medical device companies evaluate the stability of their drug candidates and finished products under a variety of stress conditions, ensuring ...

BySTEMart


STEMart Launches Pyrogenicity Testing Service for Medical Devices

STEMart Launches Pyrogenicity Testing Service for Medical Devices

STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches Pyrogenicity Testing service for the medical device industry. This new testing follows the biocompatibility guidelines ...

BySTEMart


Formal System Testing for Medical Devices – Part 2

Formal System Testing for Medical Devices – Part 2

Verification is critical for medical device testing, which is why we recommend reading part one if you haven’t already. In part one of this series, we examined the need for medical testing and briefly covered the first few aspects of device verification. ...

ByMinnetronix Medical


Guided Therapeutics Receives News from Chinese State Food and Drug Administration that LuViva Meets Product Technical Requirements

Guided Therapeutics Receives News from Chinese State Food and Drug Administration that LuViva Meets Product Technical Requirements

(OTCQB: GTHP), the maker of the LuViva™ Advanced Cervical Scan, based on its patented biophotonic technology, announced today its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), has received notice from the Jinan Medical Device Quality Supervision and Testing ...

ByGuided Therapeutics, Inc.


US. Sen. Tammy Baldwin visits Attwill Medical Solutions

US. Sen. Tammy Baldwin visits Attwill Medical Solutions

Attwill Medical. Solutions is one of the largest manufacturers of reagents for COVID-19 and other PCR testing kits, and. has unique freeze-drying technology, which may be utilized for the development of vaccines in a pill. form. In addition, they have produced many other lifesaving medical device technologies, and are. assisting ...

ByAttwill Medical Solutions


Premier Inc. Awards BioSerenity Contract

Premier Inc. Awards BioSerenity Contract

Pierre-Yves Frouin, BioSerenity CEO states, “Being a contracted provider with Premier furthers our commitment to bring world class medical devices and technological solutions to hospitals.” He also added, “BioSerenity is committed to improving patient care by making diagnostics more readily available. ...

ByBioSerenity


AventaMed selected as Test Case for RWE by NESTcc

AventaMed selected as Test Case for RWE by NESTcc

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announces twelve new Test-Cases which leverage Real-World Evidence (RWE) and address key priorities for medical device stakeholders. These ...

ByAventaMed DAC


Fretting Corrosion Causes Recall of Drug Delivery Medical Device

Fretting Corrosion Causes Recall of Drug Delivery Medical Device

The lubricant has been added to the preventive maintenance plan for all of the medical devices involved in the recall. One company that has been instrumental in helping manufacturers of medical devices test their products and provide problem solving expertise is EMSL Analytical, Inc. EMSL’s ...

ByEMSL Analytical, Inc.


ASTM F1980 - 07(2011) standard guide for accelerated aging of sterile barrier systems for medical devices

ASTM F1980 - 07(2011) standard guide for accelerated aging of sterile barrier systems for medical devices

Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are ...

ByASTM International


ASTM F1541 - 02(2011) standard specification and test methods for external skeletal fixation devices

ASTM F1541 - 02(2011) standard specification and test methods for external skeletal fixation devices

Scope 1.1 This specification provides a characterization of the design and mechanical function of external skeletal fixation devices (ESFDs), test methods for characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria. ...

ByASTM International

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