Blog
Beyond Standard Testing: Exploring the Benefits of Custom Preclinical Solutions
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...
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...
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...
What Could a PFAS Phase-out Mean for Medical Product Manufacturers?
At the end of 2022, one of the world's largest manufacturers of PFAS (per- and polyfluoroalkyl substances) announced it would stop making the compounds and...
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...
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...
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...
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...
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...
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...
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,...
Understanding the Complex Combination Product Pathway
Combination products—as the name suggests—represent a mixture of medical products. They comprise any combination of a drug and a device; a biological product...