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...
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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...
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...
When Drug Meets Device
When a medicinal product (drug or biologic) meets a medical device, a combined product is created. Incompatibility...
Understanding the EU Medical Device Regulation for Device Companies
The new European Union (EU) Medical Device Regulation (MDR), effective from May 2020, will significantly impact medical...
Navigating upcoming changes in Chemical Characterization according to revised ISO 10993-18
The final draft revision of part 18 of the ISO 10993 series, now titled “Chemical Characterization of...
Biocompatibility and the New MDR
This presentation will provide an in-depth overview of biocompatibility in compliance with the new Medical Device Regulations...
Biocompatibility: Applying the New ISO 10993 Standards
Biocompatibility is a critical aspect of medical device development, ensuring that devices are safe and do not...
Becoming Compliant with the MDRs, A Real Life Case Study
The new Medical Device Regulations (MDRs) became enforceable in May 2022. This significant regulatory shift requires that...