medical device standard News
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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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ASTM F2038 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications. Silicone manufacturers supplying materials to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly, or ...
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The state drug administration issued five medical devices regulations
Recently the state food and drug supervision and administration bureau released five related medical devices regulations come into force as of June this year to the new revision of the regulations on the supervision and administration of medical devices, authorized by the state administration of the in-depth research, many times, on the basis of demonstration, solicit opinions from all sides, and ...
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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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Materials and application methods of disinfection and sterilization packaging
Paper or plastic "has a new meaning when it is related to the disinfection of instruments in dental clinics. As a medical device, there are strict standards for the production of sterilization packaging. Disinfection and sterilization bags are usually made of paper and plastic and are a key component of any sterility assurance. The goal of the dental infection control program is to reduce the ...
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BSI group America Inc. Announces specialized regulatory training courses for the healthcare industry
BSI Group America Inc., a leading provider of total solutions for certification and standards announces the launch of Specialized Regulatory Training courses targeted specifically for the medical device industry. Available on-site, these Specialized Regulatory Courses reflect requirements of the latest amendments to the Medical Device Directive enabling attendees to comply efficiently with ...
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ASTM F2042 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties. Silicone manufacturers supplying material ...
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Scion Medical Technologies Receives ISO 13485 Certification
Newton, MA– Scion Medical Limited was awarded ISO 13485 certification both for its China manufacturing facility in Taizhou, China and for its US subsidiary, Scion Medical Technologies LLC. ISO 13485 is an internationally recognized quality standard for medical devices. ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of ...
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Oncomfort receives ISO 13485:2016 certification
ncomfort, the leader in Digital Sedation™, a digital therapy to relieve patient anxiety and pain, today announces that it has obtained the ISO 13485:2016 certification by certification company DARE!! Services. This certification confirms that Oncomfort manages the design, manufacturing and distribution of its Digital Sedation™ medical device and its Sedakit™, in its quality ...
By Oncomfort
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Exsomed Corporation Announces Completion of MDSAP Certification and ISO 13485:2016 Audit With Zero Findings
ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, announced that it has successfully completed Medical Device Single Audit Program (MDSAP) certification and ISO 13485:2016 audits, with no open findings. MDSAP is a program that allows for one regulatory audit of a medical device manufacturer’s ...
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BioVentrix Receives 2021 NUB Status 1 Reimbursement Renewal in Germany for the Revivent TC TransCatheter Ventricular Enhancement System
BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter based Ventricular Restoration (TCVR), today announced that the German Institute for Hospital Remuneration (InEK) has renewed the NUB Status 1 reimbursement designation in Germany for the Revivent TC™ TransCatheter Ventricular Enhancement System used in LIVE™ ...
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Rapid development of Precision medical Continuous attention to medical equipment
Market review for last week In Sector, Shanghai and Shenzhen index (2015/3/9-2015/3/13) up 3.36% last week, all the plates in the bank, computer up front, better medicine plates, up 2.82%. Medicine in each sector, the best of medical equipment, or 6.21%, medical services (4.85%), traditional Chinese medicine (3.14%) and business (3.07%) were relatively good medicine, biological products (2.29%) ...
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Liberate Medical Announces CE Marking for its VentFree Respiratory Muscle Stimulator
Liberate Medical, a medical device company developing novel non-invasive electrical muscle stimulation devices to help patients with pulmonary conditions, today announced that it has received CE marking for its VentFree™ Respiratory Muscle Stimulator and ISO 13485 certification for its quality management system. The VentFree stimulator applies proprietary non-invasive electrical ...
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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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V-Wave Receives CE Mark for the Ventura Interatrial Shunt System
V-Wave Ltd., a privately held medical device company developing novel implantable devices for the treatment of Heart Failure (HF), today announced that its Ventura™ Interatrial Shunt System received CE Mark and is now approved to be marketed for use in the European Union. “More than 26 million people suffer from chronic heart failure worldwide, and HF remains ...
By V-Wave Ltd.
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V-Wave receives second FDA breakthrough device designation: interatrial shunt for pulmonary arterial hypertension
V-Wave Ltd., a privately held medical device company developing novel implantable devices for the treatment of Heart Failure (HF), today announced that its Ventura™ Interatrial Shunt System received CE Mark and is now approved to be marketed for use in the European Union. “More than 26 million people suffer from chronic heart failure worldwide, and HF remains a leading driver of ...
By V-Wave Ltd.
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