A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially … [Read more...] about Premarket Notification: 510(k) FDA
How We Conduct ISO 10993 Medical Devices Evaluations
The goal of ISO 10993 is to protect patients from biological risks arising from the use of medical devices. The standard covers testing for … [Read more...] about How We Conduct ISO 10993 Medical Devices Evaluations
Preparing for New Regulations of Elemental Impurities in Drugs
Drug and dietary supplement manufacturers face an increasingly complex set of elemental impurity standards, which we will detail here. USP … [Read more...] about Preparing for New Regulations of Elemental Impurities in Drugs
Jordi Labs’ Kevin Rowland featured in invitation-only panel discussion at the E&L USA 2017 conference
Jordi Labs' laboratory manager, Kevin Rowland, participated in an invitation-only panel discussion at the Extractables & Leachables USA 2017 … [Read more...] about Jordi Labs’ Kevin Rowland featured in invitation-only panel discussion at the E&L USA 2017 conference
Jordi Labs’ President, Dr. Mark Jordi, presents at BIOMEDevice Boston 2017
https://youtu.be/GsrTDhImA2A Jordi Labs proudly presented at the at BIOMEDevice Boston 2017, on May 3 & 4, 2017 at the Boston Convention & … [Read more...] about Jordi Labs’ President, Dr. Mark Jordi, presents at BIOMEDevice Boston 2017
