Recent FDA biocompatibility feedback from 510k submissions
Navigating the FDA approval process for a medical device can be a daunting and stressful experience for...
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Shifting Requirements Within the FDA: Expectations in Chemistry Study Design
The FDA’s expectations regarding the design of chemistry studies in support of medical device toxicology have been...
Chemical Characterization on a Combination Device for Biological Evaluation Plan to Practice
Join Dr. Annelies Vertommen and Dr. Sophie Michel in this insightful webinar as they delve into the...
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...
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...
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...
Biocompatibility of Raw Materials for Medical Devices
Starting with a biocompatible material is crucial for medical device manufacturers. However, regulatory requirements are pushing manufacturers...
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...
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...