Fly through Regulatory Approval with Biological Evaluation Plans

Fly through Regulatory Approval with Biological Evaluation Plans

The Biological Evaluation Plan (BEP) is your superpower serving as a detailed guide for every device, every development phase. From describing the device’s materials and configuration, to the manufacturing processes and intended clinical use, the BEP aligns your device with regulatory expectations to streamline regulatory submissions. With expert guidance, this living document ensures device safety throughout the entire lifecycle. Taking into consideration intended clinical use or foreseeable misuse, the BEP categorizes the device by its type of tissue contact, frequency, duration of use, and sets criteria for biological risk acceptability, giving your device the power to fly through regulatory submission.

During this webinar you will learn:

• The importance of biological evaluation within a risk management approach
• How to develop a cost-effective and comprehensive BEP aligned with regulatory expectations
• Insights into the categorization of devices
• The latest revisions and standard updates following the October 2024 ISO TC 194 meeting.