RQM+ Medical Device and In Vitro Diagnostic Blog

on 27 June 2024 | By Kaitlin Lerner, Vice President, Lab Services

Chemical characterization is an integral part of the life sciences industry. It factors into all aspects of pharmaceutical and medical device development, from preclinical research and early risk analysis to post-marketing surveillance of end products. The approach varies,...

on 26 June 2024 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Analytical testing is a cornerstone of pharmaceutical development. It is, of course, essential for ensuring the efficacy and safety of drugs released to market. But compliance and process optimization needs go hand-in-hand with product QA/QC. Various test methodologies factor...

on 14 May 2024 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Failure analysis is a critical field used to detect chemical and mechanical defects in polymeric materials, pinpointing the factors that have contributed to or directly resulted in product failure. This analytical discipline plays a pivotal role in enhancing the properties and...

on 2 April 2024 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Regulations in both the EU and US are rapidly changing in order to address the health and environmental risks posed by per- and poly-fluoroalkyl substances (PFAS). Through the EU REACH regulation, it has been proposed to restrict PFAS which will preclude manufacturers from...

on 15 March 2024 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company

Extractables and leachables are potentially hazardous chemicals that a patient can be exposed to when using medical devices or drug products. These chemicals may be present as impurities in the materials used, but also may be introduced during manufacturing or storage....