Design Control for the Contract Research Organization
Design Control is a fundamental requirement set forth by the FDA, detailed in 21 CFR 820. It...
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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)...
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...
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...
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....
Chemical Disinfection Validations for Reusable Devices
Chemical disinfection validations for reusable devices are critical to ensure the safety and efficacy of medical devices...
The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
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...