US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
Browse Content
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...
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...
Internal Audit Be Ready for FDA Inspections Hope is not a Strategy
Life science companies recognize that the FDA inspection process is a cornerstone of ensuring the safety and...
Implementing Risk Managed Supplier Quality
A risk-managed approach to the global supply chain is more important than ever for life science manufacturers....
GMPs for Early Stage Development Projects
Good Manufacturing Practices (GMPs) should be implemented during the later stages of clinical development, where the final...
Developing a Quality System on a Budget
Developing a robust quality system is fundamental to ensuring that an organization’s products or services are safe,...
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...
Animal Testing
Traditionally, animals have been used as test subjects during drug development studies to reliably detect the toxic...
Meeting the Requirements of 10.4 of MDR How to Address CMRs
Ensuring compliance with the Medical Device Regulation (MDR) requires a thorough evaluation of medical devices for the...