If Something Looks Clean, Is It Really Clean? Cleaning Validations for Reusable Devices
Reprocessing validations of reusable medical devices have often been overlooked. However, the upcoming Medical Device Regulation (MDR)...
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MDR/IVDR – How MedPharmPlast is Helping Overcoming the Potential Challenges
The implementation of MDR/IVDR regulations makes it imperative for Original Equipment Manufacturers (OEMs) to have a comprehensive...
ISO 10993-18 in the MDR: understanding the restrictions and risk assessment for compounds which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties (section 10.4)
In this comprehensive webinar, we will explore the crucial role of chemical characterization studies (ISO 10993-18) in...
Face Masks and Respirators
In this Nelson Labs webinar, we will provide a thorough understanding of the critical differences between medical...
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...
