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Medical Device Standard Articles & Analysis
16 news found
Many medical devices are manufactured through plastic injection moulding, which allows for precise and top-quality components in large-scale production and better aligns with ISO standards. ...
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 devices. ...
BySTEMart
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. ...
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. ...
BySTEMart
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 ...
BySTEMart
This certification confirms that Oncomfort manages the design, manufacturing and distribution of its Digital Sedation™ medical device and its Sedakit™, in its quality management system according to the latest regulatory requirements in the medical field. ...
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 ...
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. ...
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. ...
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. ...
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. ...
On March 12, the CFDA released about approval to release the hemodialysis and related water treatment, etc. The announcement of 90 standards for medical devices industry. Investment Advice: With the improvement of people's health awareness and the promotion of the concept of "treating disease," the medical environment will ...
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, ...
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 ...
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 ...
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. ...