Risk Assessment for Single Use Systems: USP 665 vs. BPOG
Disposable plastic components are increasingly popular in biopharmaceutical drug manufacturing systems due to their cost-effectiveness and reduced...
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2022 Industry Outlook Medical Device
In this episode, host Brandon Miller is joined by Seyed Khorashahi and Thor Rollins to explore the...
Understanding the Power of the FDA Pre-Sub: Tips for a Successful Meeting
The submission process to the FDA can be a stressful and uncertain time for a medical device...
Design Change Impact on Biocompatibility and Documentation
Change management in the design of medical devices is a critical process, frequently highlighted in FDA 483...
The Big Three: Cytotoxicity, Sensitization & Irritation Testing
Among the myriad of tests that medical device manufacturers must conduct, none are more critical than the...
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...
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...
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....
The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list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...