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Biological Evaluation for Medical Devices

Overview

The AAMI Biological Evaluation Course provides a comprehensive guide to preparing Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER) for medical devices. Through an in-depth exploration of regulatory expectations and technical requirements, this course equips participants with the skills necessary to assess device biocompatibility, leverage existing data, and incorporate toxicological risk assessments into the BEP. Participants will gain practical knowledge to ensure compliance with ISO 10993 and related standards, ensuring the safety and effectiveness of medical devices. 

Objectives

Upon completion of this course, participants will be able to: 

  1. Understand the regulatory requirements and key components involved in preparing a BEP and BER for medical devices. 

  1. Accurately categorize medical devices and conduct comprehensive device and materials characterization. 

  1. Select appropriate biological endpoints and biocompatibility tests, ensuring data quality and regulatory compliance. 

  1. Prepare test articles and interpret results to assess biocompatibility effectively. 

  1. Leverage existing biocompatibility data and incorporate it into BEP documentation. 

  1. Integrate toxicological risk assessments into the BEP to evaluate potential risks associated with device materials. 

  1. Prepare a thorough and compliant BER that reflects the results of biological evaluations and risk assessments. 

Who Should Attend?

This course is ideal for professionals involved in the biological evaluation of medical devices, including: 

  • Regulatory affairs specialists and managers responsible for device submissions. 

  • Quality assurance professionals overseeing compliance with biocompatibility standards. 

  • Biomedical engineers and scientists engaged in product development and testing. 

  • Medical device professionals working on toxicological risk assessments and material safety evaluations. 

  • Consultants or advisors who support medical device companies in preparing regulatory submissions. 

This course is suitable for those new to biological evaluation, as well as experienced professionals looking to deepen their understanding of current regulatory and technical expectations.

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.