Updates to Med Device E & L What about Chemistry on Limited Contact Devices
Recent feedback from global regulatory bodies has increasingly emphasized the necessity of extractables and leachables (E&L) chemistry...
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After E&L Updates to the Standard for Toxicological Risk Assessment 10993-17
The use of extractables and leachables (E&L) chemistry testing has become integral and often essential in the...
Impact of MDR on Biocompatibility, a Shortage of Expertise
As the deadline for the Medical Device Regulation (MDR) approaches, many medical device manufacturers are rushing to...
Biocompatibility for Medical Devices 101 – Prepare for Clinical Trial
This is a crash course overview of medical device biocompatibility, designed to provide a comprehensive understanding of...
Shifting Requirements Within the FDA: Expectations in Chemistry Study Design
The FDA’s expectations regarding the design of chemistry studies in support of medical device toxicology have been...
Understanding the EU Medical Device Regulation for Device Companies
The new European Union (EU) Medical Device Regulation (MDR), effective from May 2020, will significantly impact medical...
Becoming Compliant with the MDRs, A Real Life Case Study
The new Medical Device Regulations (MDRs) became enforceable in May 2022. This significant regulatory shift requires that...
3D Printed Medical Devices and Biocompatibility Whitepaper
The use of three-dimensional (3D) printing techniques to address challenging fabrication problems has become mainstream over the...
Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices
3D-printed orthopedic medical devices have gained significant attention due to their potential for enhanced biocompatibility, customizability, and...