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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...
Class II Medical Device Verification and Validation: What Goes into it?
Understanding Medical Device Verification and Validation When it comes to ensuring the safety and efficacy of medical devices, rigorous processes are in place...
Medical Device Industry Trends to Watch
Medical Device Industry Trends for 2024 and Beyond The medical device industry is constantly evolving, driven by advancements in technology, changing...
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...
What to Look for in Medical Device Component Manufacturers
Quality Medical Devices Start with a Quality Manufacturer Medical device component manufacturers are the backbone of your Class II medical device operation....
What is the Class II Medical Device Design and Development Process?
Innovation plays a pivotal role in enhancing patient care, diagnostics, and treatment outcomes. One critical aspect of this innovation is the design and...
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...
Benefits of Class II Medical Device Contract Manufacturing
Partnering with a Class II Medical Device Manufacturing Company Saves Time and Money Class II medical device manufacturing requires precision,...
Understanding Medical Device Conceptualization and Research
A Guide to Medical Device Conceptualization and Research Do you have an idea for a Class II medical device, but you’re not sure where to start? You’re not...
The Complete Guide to Class II Medical Device Development
The Step-by-Step Guide to Creating a Life-Changing Class II Medical Device Navigating the Class II medical device development process can be overwhelming....
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...