Medical Device Management
Articles & Whitepapers
-
SmartFreezer®: Meeting the Medical Device Directive for Safe Sample Management
Medical devices are an essential component of healthcare, and they have significantly improved the quality of life for many patients worldwide. These devices may be categorised by their intended use and range from simple non-invasive items to fully implantable devices. The Medical Device Directive 93/42/EEC (MDD) is a regulation that sets out the essential requirements that medical devices must ...
-
A Quick Overview of ISO 13485 Requirements for Medical Device Companies
It is an undeniable fact that safety and quality are the top-most priority for medical device companies. However, the best-practices to maintain these priorities are defined under ISO 13485. You ...
News
-
CardioWise™ Receives ISO 13485:2016 Clearance for Design, Development, and Marketing of Software as a Medical Device (SaMD) For the Medical Device Industry
CardioWise, Inc., is pleased to announce that Perry Johnson Registrars, Incorporated has audited the CardioWise Quality Management System (QMS) and determined CardioWise is in conformance with ISO 13485:2016. Perry Johnson Registrars Certificate ...
STEMart Launches Microbiology & Sterility Testing Services for Medical Devices
New Bone Data Comparing ImpediMed’s SOZO to DXA in Cancer Patients to be Presented at 39th Annual Miami Breast Cancer Conference
New Data Show Statistically Significant Reduction in Chronic Cancer-Related Lymphedema with Early Detection Using ImpediMed’s L-Dex® Technology and Intervention
Hyalex Receives ISO 13485 Certification
Equipment & Solutions
-
Showcase
Adsorber
The CytoSorb adsorber is a CE-marked Class IIb medical device that is specifically approved for the removal of cytokines, bilirubin and myoglobin. Next to this CytoSorb is indicated for use intraoperatively during cardio-pulmonary bypass surgery for the removal of P2Y12-Inhibitor Ticagrelor and/or Factor Xa-Inhibitor. It is approved for use with standard hemodialysis-, hemofiltration-, ECMO- and ...