Medical device industry is preparing to fulfill the requirements of the new EU medical device regulation (MDR) and are faced with increased focus on assessing and documenting the safety of medical devices. In addition, the international standards in the ISO 10993-series on biocompatibility and biological safety evaluation of medical devices are being updated. Keeping the overview of the requirements and how to fulfill them can be a challenge.
In a series of three webinars on safety assessment of medical devices, this first webinar gives you an overview of the requirements in the MDR and updates to the ISO 10993-series. We will address how to approach the safety evaluation including key requirements and help you by pointing out useful standards and guidelines to ensure compliance.
You will learn about:
• Main MDR requirements relating to device safety and biocompatibility, including:
- General requirements to chemical, physical and biological properties
- Hazardous substances in medical devices
• Main updates to ISO 10993-1, including:
- Device categorization
- Physical and chemical characterization
- Biological endpoints to evaluate
- Structuring the approach and collection of data
- Data-gap analysis and selection of non-clinical testing for biocompatibility
• Overview of updates to the ISO 10993-series and other relevant guidelines
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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