When drug meets device: How to assess compatibility?
The frequent use of combined products, which involve the joint application of drugs and medical devices, underscores...
Archives: Courses
The Biological Evaluation Plan (BEP): A crucial first step in the Biocompatibility evaluation of a Medical Device
Evaluating the biocompatibility of medical devices is a critical step in ensuring patient safety, and it should...
Supply Chain Management Audit Effectiveness and Oversight
With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are...
The Essence Of The EU MDR and its Key Consequences
The enhanced focus of the European Union Medical Device Regulation (EU-MDR) on biocompatibility and toxicity represents a...
ICH Stability Testing and Method Development
Stability testing is an essential component of product development, conducted throughout the entire lifecycle of a biotherapeutic...
Biocompatibility of Raw Materials for Medical Devices
Starting with a biocompatible material is crucial for medical device manufacturers. However, regulatory requirements are pushing manufacturers...
The New ISO 10993 – 18 Standard and its Impact on Chemical Characterization of Medical Devices
In response to the heightened focus on chemical characterization outlined in ISO 10993-1:2018, a significant revision of...
Changes to ISO10993-1 and relationship to Medical Device Regulation
The 2018 revision of ISO 10993-1 aligns closely with the Medical Device Regulation (MDR) to provide clearer...
Design Control for the Contract Research Organization
Design Control is a fundamental requirement set forth by the FDA, detailed in 21 CFR 820. It...
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....
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...
Coronavirus & Barrier Material Tests
According to the CDC and OSHA, the minimum recommended protection against possible contact with the coronavirus is...
Establishing the Proper Alcohol/Water Proportion for Simulating Solvents Used in Controlled Extraction Studies
The purpose of this whitepaper is to provide comprehensive guidance on determining the appropriate alcohol/water proportion for...
FAQs for Pet Treats Manufacturers: Get the Facts on Pathogen Reduction in Pet and Animal Nutrition
If you’re a manufacturer looking to reduce bacteria in pet treats and animal feed that you sell...
Get the Facts on Bioburden Control and Sterilization for Food & Beverage Packaging
This eBook, 'Get the Facts on Bioburden Control and Sterilization for Food & Beverage Packaging,' addresses common...