2022 State of the Medical Device Industry Quality, Biocompatibility, and Changing Regulations
As another year unfolds with regulatory changes, updated mandates, and the ongoing impacts of the COVID-19 pandemic,...
Browse Content
Testing and Risk Management Impacts Changing Medical Device
Change management, particularly related to a medical device’s design, is one of the most commonly cited issues...
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...
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....
