medical device testing News
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Fretting Corrosion Causes Recall of Drug Delivery Medical Device
This past November, the U.S. Food and Drug Administration (FDA) announced a Class 1 recall of the Ikaria INOmax DS Drug Delivery System. The device is a drug delivery system used with ventilators to deliver a preset concentration of INOmax therapy gas (nitric oxide for inhalation) for critically ill patients. According to the FDA posting regarding the recall, “Fretting corrosion at the ...
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Protheragen-ING Lab, a Trustworthy GLP Service Provider, Unveils Its Cutting-Edge Medical Device Services
Protheragen-ING Lab, a well-known and reputable Good Laboratory Practices (GLP) service provider, has recently unveiled its cutting-edge medical device services. With a track record of excellence and reliability in providing high-quality services to the pharmaceutical and biotechnology industries, Protheragen-ING Lab is now expanding its offerings to include comprehensive solutions for medical ...
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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 modified for medical devices. Due to the risks associated with medical devices, comprehensive medical device testing throughout the product ...
By STEMart
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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. In this article, we’ll cover the verification dry run and the formal verification process that makes new medical products a reality. ...
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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 their safety and efficacy throughout their shelf life. Forced ...
By STEMart
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STEMart Launches Biological Indicator Sterility Testing Service for Medical Devices
STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced Biological Indicator Sterility Testing services for the industry of medical devices. This testing is performed according to the exposure of Biological Indicators (BIs) after completion of the sterilization load, and it is a qualitative test to reveal results that can ...
By STEMart
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US. Sen. Tammy Baldwin visits Attwill Medical Solutions
Attwill Medical Solutions was proud to host U.S. Senator Tammy Baldwin (D-WI) today for a. roundtable discussion regarding the company, as well as a comprehensive factory tour. 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. ...
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STEMart Launches Microbiology & Sterility Testing Services for Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, introduces comprehensive microbiology and sterility testing for sterile, non-pyrogenic products. STEMart has extensive expertise in microbiology as well as sterility testing and remains dedicated to a full-service experience that supports manufacturers in meeting ...
By STEMart
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Guided Therapeutics Receives News from Chinese State Food and Drug Administration that LuViva Meets Product Technical Requirements
Guided Therapeutics, Inc. (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 Center of the State Food and Drug ...
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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 Test-Cases are intended to accelerate NESTcc’s progress and provide proof of concept for NESTcc’s ...
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ASTM F1541 - 02(2011) standard specification and test methods for external skeletal fixation devices
A1.4.1 The purpose of this classification is to establish a consistent terminology system by means of which these ESFD configurations can be classified. It is anticipated that a companion testing standard using this classification system will subsequently be developed. 1. Scope 1.1 This specification provides a characterization of the design and mechanical function of ...
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ASTM F1980 - 07(2011) standard guide for accelerated aging of sterile barrier systems for medical devices
The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling. ISO 11607–1:2006, clause 6, states that “the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile ...
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STEMart Introduces Biocompatibility Evaluation of Breathing Gas Pathways in Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, expands its Biocompatibility Testing services and introduces biocompatibility evaluation of breathing gas pathways in medical devices. This new testing follows the biocompatibility guidelines modified for medical devices and uses a solid scientific rationale. ...
By STEMart
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Premier Inc. Awards BioSerenity Contract
BioSerenity, Inc., a leading global provider of diagnostic solutions in the areas of Sleep Medicine, Neurology, and Cardiology, announced today it has been awarded a group purchasing agreement for PP-SV-268 by Premier as part of its Preferred Partner agreement. The prevalence of sleep disorders, epilepsy and cardiovascular disease pose a significant challenge to the US healthcare system. ...
By BioSerenity
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STEMart Launches Bioburden and Sterility Testing for Medical Devices
STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced the Bioburden and Sterility Testing services for medical devices under the guidance of the ISO 11731 method. For medical device manufacturers, sterility assurance is a vital part in producing safe products. The FDA and other regulatory agencies require validation of ...
By STEMart
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STEMart Introduces New Antibiotic Potency Tests for Medical Devices
STEMart, a provider of CRO services dedicated to integrated medical device and diagnostic clinical development, introduced new Antibiotic Potency Tests to assess the bioactivity or potency of various antibiotics for medical devices. The development of these new tests strictly follows the Antibiotics-Microbial Assays in USP General Chapter 81 to ensure the highest efficacy. Microbial potency ...
By STEMart
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Bemis, DDL, Earth911 and Heinz Join the American Institute for Packaging and the Environment (AMERIPEN)
The American Institute for Packaging and the Environment (AMERIPEN) announced that four additional companies in the packaging value chain have joined the organization as Voting Members: Bemis Company, Inc., an international supplier of flexible packaging and pressure-sensitive materials; DDL, a medical device product, packaging and materials testing services ...
By Ameripen
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ViGeneron and WuXi Advanced Therapies enter Strategic Manufacturing Partnership For Next-Generation Ophthalmic Gene Therapy
ViGeneron, a gene therapy company, and WuXi Advanced Therapies Inc. (WuXi ATU), a leading Contract, Testing, Development and Manufacturing Organization (CTDMO), today announced a strategic partnership to accelerate production for the clinical development of VG901, a next-generation ophthalmic gene therapy program. ViGeneron’s innovative gene therapy pipeline addresses ophthalmic diseases ...
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ViGeneron Announces Closing of Series A Financing to Drive Development of Next Generation Gene Therapy Pipeline
ViGeneron GmbH, a gene therapy company, announced the closing of its series A financing round led by WuXi AppTec and Sequoia Capital China. The proceeds will enable ViGeneron to accelerate its proprietary viral vector-based gene therapy platforms and drive product development in its two lead ophthalmic gene therapy programs. Funds will advance development of ViGeneron’s next-generation ...
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BloodCenter of Wisconsin and Eastman Chemical Company announce new blood bag clinical trial results
BloodCenter of Wisconsin (BCW, part of Versiti) and Eastman Chemical Company (NYSE:EMN) have announced the results of a recent clinical trial evaluating a new plasticizer for blood bags. While di-2-ethylhexyl phthalate (DEHP) has provided the medical industry with a stable ortho-phthalate plasticizer for many years, regulatory trends and consumer demands will inevitably drive the industry to ...
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