Recent FDA biocompatibility feedback from 510k submissions
Navigating the FDA approval process for a medical device can be a daunting and stressful experience for...
Browse Content
Discussion of Feedback Received Directly from FDA on ChemTox
In this webinar, we will share the latest trends in feedback received from the FDA concerning extractables...
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...
FDA Feedback Reguarding Chemistry for Toxicological Risk Assessment – How to Make Sure FDA will Accept Your Protocol
Understanding the latest trends in FDA feedback regarding extractables chemistry testing is crucial for ensuring compliance and...
COVID-19, what we learned from the race to supply the market with respirators, masks, and other PPE
During these unprecedented times, medical device companies have had to be exceptionally agile and responsive. During the...
Meeting the Requirements of 10.4 of MDR How to Address CMRs
Ensuring compliance with the Medical Device Regulation (MDR) requires a thorough evaluation of medical devices for the...
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...
EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7
Sterilizing medical devices via ethylene oxide (EO) gas is an effective and widely used practice within the...
Biocompatibility: Applying the New ISO 10993 Standards
Biocompatibility is a critical aspect of medical device development, ensuring that devices are safe and do not...
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...
