Iso 13485 Standard Articles & Analysis
10 news found
They can also be used as optimization tools, calibration standards, reference materials, and quality control tools.However, sourcing these sera can be complex and time-consuming, and it can sometimes be impossible to find suitable materials. ...
The 10,000 square foot operation was recently certified by the designated European Notified Body, BSI, to International Standards Organization (ISO) 13485:2016. “Expansion and ISO certification of our California headquarters will enable us to add additional personnel as we prepare to submit the Altius System Pre-Market ...
We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. ...
BioXtreme is proud to announce that, following our ISO-13485 certification from the Israeli Standards Institution (www.sii.org.il), it has received its CE Marking, based on self declaration. ...
“The Tissue Genesis team designed the Icellator X to become the gold standard in automated stem cell isolation,” said Dr. Rolf Wolters, Director of Product Management, Tissue Genesis. ...
Manufactured under cGMP to the highest ISO 13485 and FDA standards, the Icellator® provides yields of stromal vascular fraction that is sufficiently pure to allow for intravenous infusion in an hour or less. ...
Manufactured under cGMP to the highest ISO 13485 and FDA standards, the Icellator® requires no human intervention and provides yields of stromal vascular fraction that is sufficiently pure to allow for intravenous infusion in an hour or less. ...
We are excited to announce that SteriLux has received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Lloyd’s Register. This ISO certification indicates that the company’s quality management system meets the most current regulatory requirements specific to the medical device industry. “We are ...
Transluminal Technologies has been assessed and approved by BSI Group America against the provisions of ISO 13485:2003. Successful registration assures the firm’s quality management systems comply with requirements established by the International Organization for Standardization (ISO). ISO ...
(NYSE: A) today announced that its liquid chromatography/mass spectrometry systems, including 6100 Series single quadrupole and 6400 Series triple quadrupole systems, are now manufactured under ISO 13485 certification. This is an internationally recognized standard of quality management for the design and manufacture of medical devices. ...