The Testing and Risk Management Impacts of Changing a Medical Device
Throughout its product life cycle, a medical device and its support system can undergo numerous changes—sometimes even...
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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...
Evaluating the biocompatibility of reusable medical devices during their whole life cycle
In the past, the primary focus for reusable medical devices was on validating reprocessing efficacy with regard...
MDR with Brexit_ How the Combination is Impacting the European Medical Device Industry
With the COVID-19 crisis, the implementation of the Medical Device Regulations (MDR) was delayed by one year....
Requirements and Impact of the New Guideline – ISO 10993-23: Tests for Irritation
The landscape of biocompatibility testing for medical devices is evolving with the recent shift of irritation assessment...
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...
The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
A Delay in MDR? Where are we now?
With the onset of the COVID-19 crisis, the implementation of the Medical Device Regulations (MDR) has been...
Recent FDA biocompatibility feedback from 510k submissions
Navigating the FDA approval process for a medical device can be a daunting and stressful experience for...
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...