Face Masks and Respirators
In this Nelson Labs webinar, we will provide a thorough understanding of the critical differences between medical...
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Packaging Trends Leading to Increased 483’s
In this presentation, we will explore recent packaging trends in the medical device industry, particularly those highlighted...
A Review of Ionizing Radiation Sterilization Modalities
High-energy ionizing radiation is an established and proven method for sterilizing healthcare, food, and general industrial products....
US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
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,...