In an increasingly complex world, one size rarely fits all. In most preclinical studies, testing services can be bought off-the-rack and fulfill all the needs and desires of a device manufacturer or drug developer/sponsor. But sometimes, a custom fit is necessary....
Regulatory
What Manufacturers Need to Know About the MDR Deadline Extension
In March 2023, the European Parliament handed medical device manufacturers some breathing room when it amended the Medical Device Regulation (MDR) to allow for a longer compliance period for certain medical devices and in vitro diagnostic devices. The move was...
Understanding ‘Assumed Release’ in ISO 10993-17:2023
The latest update to ISO 10993-17:2023 introduces significant changes to how medical device manufacturers and toxicologists can estimate and incorporate constituent release into the toxicological risk assessment (TRA) process. We explore the concept of release...
Navigating Cytotoxicity Failures in Medical Devices: Comprehensive Risk Management Strategies
Cytotoxicity testing is one of the standard biocompatibility tests for nearly all medical devices irrespective of their duration and nature of patient contact per ISO 10993-1:2018 and the U.S. FDA's Guidance on the Use of ISO 10993-1 (2020). Although cytotoxicity...
Beyond UV: Harnessing LC-MS for Comprehensive Medical Device Chemical Characterization
As the world of medical technology progresses, so does the landscape of regulatory expectations. Gone are the days when unknown chemicals would be allowed or accepted in preclinical testing. For today's regulatory bodies, ambiguity in chemical characterization is no...
Medical Device Packaging Validation: 5 Testing Best Practices for 2023
Medical device packaging validation helps ensure that a medical device cleared for commercialization will arrive to the end-user in an uncompromised, sterile state, and non-sterile product remains uncompromised during its journey to the user. Here are five important...
How ISO 10993-17:2023’s Toxicological Screening Limit Can Change the Game for Medical Device Manufacturers
Medical device developers are constantly looking for regulatory changes that may impact how they work. Sometimes minor changes in regulation can make their lives a lot easier, while alterations add extra steps to a process elsewhere. Changes to ISO 10993-17 have been...
Using High Resolution Gas Chromatography to Keep Costs in Control While also Protecting Patients
High-resolution quadrupole time-of-flight (QTOF) gas chromatography–mass spectrometry (GC-QTOF-MS) provides a powerful combination of high mass accuracy with trace level detection capabilities. Applying the technique to extractables and leachables testing (E&L)...
Case Studies: Evolving Regulatory Trends Require Trusted Lab Testing Partners
As regulatory guidance evolves, a new expectation around preclinical medical device safety testing is emerging: Unknown chemicals are unacceptable. The new risk-based approach means regulatory bodies expect complete chemical characterization. Testing can include all...
How the Updated ISO 10993-17:2023 Could Change Toxicological Risk Assessment
When it comes to medical devices, regulatory standards are never set in stone. The guidance offered by authorities is ever evolving, as technology advances, new data becomes available and old interpretations become obsolete. As medical device manufacturers innovate,...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.