Safety assessment of drug delivery devices can be a challenge as you must meet the regulatory requirements for drugs and medical devices for the same product. Often drug delivery devices have been evaluated under the framework of being primary packaging for drugs. Now it is mandatory also to evaluate the safety and biocompatibility as a medical device.
This webinar is the third in a series of webinars on the safety requirements for medical devices.
In this webinar you will get an overview of how to approach safety evaluation of drug delivery devices in accordance with the requirements in the new EU medical device regulation (MDR) and in the updated ISO 10993-1 standard.
You will learn about:
• Device categorization
• Identification of biological hazards to evaluate
• Physical and chemical characterization
• Selection of non-clinical testing for biocompatibility
• Toxicological risk assessment of devices
In addition, you will get a summary of updates to the international standards and guidelines for evaluation of the safety and biocompatibility of medical devices that are relevant for drug delivery devices.
Professionals in RA, QA or R&D who are responsible for medical device safety in companies that manufacture, import or sell medical devices and drug-device combination products on the EU market.
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