Challenges in Design Development – Why Design Control Makes Sense
The journey from a novel idea for a new medical product to its commercial realization involves significant...
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Animal Testing
Traditionally, animals have been used as test subjects during drug development studies to reliably detect the toxic...
IVDR Regulation for Medical Device Directive in EU: Impact Assessment of Revision of the Regulatory Framework for MDD in EU
The existing regulatory framework for medical devices, which has been in place for 20 years, has recently...
Outsource Quality and Regulatory Agencies: Right-Sizing Need and Cost
Small or emerging life science organizations often face the dilemma of when to hire Quality and Regulatory...
US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
Gamma: the heart of radiation sterilization past, present and future
The COVID-19 pandemic of 2020 highlighted the pivotal role of the medical device supply chain in delivering...
Establishing Bioburden Alert and Action Levels
In the realm of bioburden, sterilization, and environmental testing, national and international standards play a crucial role...
Understanding the EU Medical Device Regulation for Device Companies
The new European Union (EU) Medical Device Regulation (MDR), effective from May 2020, will significantly impact medical...
Material Consideration Radiation Processing
Each polymer reacts differently to ionizing radiation, making it crucial to verify that the maximum administered dose...
Rapid Sterility Testing: A New Solution For Short Shelf Life Products
All drug products must undergo sterility testing to comply with Good Manufacturing Practices (GMP). Parenteral drug products,...