Description
In-person training in English, live translation in Chinese
英语线下培训，中文同声传译
Course A: Biocompatibility of Medical Devices
Two-Day Certification Course
Date: June 11-12, 2026
Location: InterContinental Suzhou
Price: $800 USD (early registration discount of $600 USD ends Sunday, May 3, 2026)
Agenda: NAMSA-Course-A-Agenda Shanghai 2026-English (Monday reception: reception with appetizers, networking with attendees and speakers)
The release of ISO 10993-1:2025, 10993-18:2020 and the Medical Device Regulation (MDR) General Safety and Performance Requirements (GSPR) bring several challenges for medical device manufacturers. The industry is experiencing the most drastic updates in the biological evaluation of medical devices since the issuance of the ISO 10993 standards.
This course is structured to tackle each of these challenges and provide hands-on experiential learning. It is designed for those who require a working knowledge of biocompatibility or are looking to update and sharpen their skills. Participants can expect to learn how to use standards to establish a biological safety evaluation plan, as well as how to document and implement their plan. Use of material/chemical characterization and risk assessment will be highlighted, as will real-world exercises to practice evaluating biological risk. (In order to be certified as a Biological Safety Specialist, participants must attend and complete all exercises over the 2-day course).
Course Objectives
Upon course completion, attendees will be able to:
- Apply the principles of ISO 10993-1:2025 to attendee’s particular challenges with medical device biocompatibility
- Discuss the FDA guidance for biological safety and distinguish where the FDA and other regulatory bodies differ and determine their use of the new ISO 10993-1: 2025
- Upgrade device technical documentation to meet the European Union’s (EU) MDR 2017/745 GSPR
- Answer the question: When is testing not the only option?
- Distinguish the difference between evaluation and testing and recognize when testing is absolutely necessary or avoidable
- Select chemical and biological tests and understand how to choose among various methods
- Utilize ISO 10993-18:2020 and material/chemical characterization information with the use of toxicological risk assessment to demonstrate biological safety
- Develop a program that guides your device on the regulatory path and reduces time to market
- Practice how to execute your plan from development to completion and how to schedule and document the implementation of your biocompatibility plan
NOTE: Our security measures require that your credit card billing address match your profile address.
Speakers
Don Pohl, BS, Principal Strategy Consultant, Biocompatibility, NAMSA
Don has been with NAMSA since 1993, working in a variety of roles involving the biocompatibility evaluation of medical devices. He has expertise in various therapeutic areas including but not limited to cardiovascular, orthopedics, neurostimulation, dialysis, wound management, combination products and drug delivery. Full biography here
Alfred Dibao-Dina, PhD, DABT, ERT, Biological Safety Scientist, NAMSA
Alfred is a toxicologist, certified by the American Board and registered in Europe, and holds a PhD in Biomedical Engineering. At NAMSA since 2017, his current role as a Biological Safety Scientist focuses on writing and reviewing Biological Evaluation Plans and Reports per ISO 10993-1 and ISO 14971 and Toxicological Risk Assessments per ISO 10993-17. He provides regular trainings, and helped with the qualification and validation of NAMSA’s chemistry laboratory in Germany. Full biography here
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英语线下培训，中文同声传译
课程A：医疗器械生物相容性
两天认证课程
日期：2026年6月11-12日
地点：苏州洲际酒店
费用：800美元（早鸟优惠价600美元截止至2026年5月3日星期日）
日程：周一欢迎酒会：含开胃小食，与参会者及讲师交流 NAMSA Training Agenda Suzhou 2026
ISO 10993-1:2025、10993-18:2020标准及《医疗器械法规》(MDR)通用安全与性能要求(GSPR)的发布，为医疗器械制造商带来多重挑战。自ISO 10993系列标准颁布以来，医疗器械生物学评价领域正经历最重大的变更。
本课程旨在针对这些挑战提供实践性体验式学习，适合需要掌握生物相容性基础知识或希望更新技能的从业者。学员将学习如何运用标准制定生物学评价计划，并掌握计划的文档记录与实施方法。课程重点涵盖材料/化学表征与风险评价，并通过真实案例演练生物学风险评价流程。（注：学员须全程参与为期两天的课程并完成所有实践环节，以获得生物安全方面的相关专业知识）。
课程目标
完成课程后，学员将能够：
- 运用ISO 10993-1:2025标准原则解决医疗器械生物相容性方面的特定挑战
- 探讨FDA生物安全指南，辨别FDA与其他监管机构的差异，并确定其对新版ISO 10993-1:2025标准的应用方式
- 升级设备技术文件以满足欧盟医疗器械法规MDR 2017/745 GSPR的要求
- 解答“何时测试并非唯一选择”的核心问题
- 区分评价与测试的本质差异，识别测试的绝对必要性与可替代性
- 筛选化学及生物测试方法，掌握多种检测手段的选择策略
- 运用ISO 10993-18:2020标准及材料/化学表征信息，结合毒理学风险评价证明生物安全性
- 制定引导器械合规路径并缩短上市周期的方案
- 实践从开发到完成的全流程计划执行，掌握生物学评价计划的实施排期与文档记录
注意：根据NAMSA的安全措施要求，您的开票地址必须与个人资料中的地址一致。
演讲嘉宾
Don Pohl，NAMSA生物相容性首席战略顾问
Don自1993年加入NAMSA，历任多个涉及医疗器械生物学评价的职位。他的专业涉及多个领域，包括但不限于心血管、骨科、神经刺激、透析、伤口护理、组合器械及药物输送相关产品。完整简历请见此处
Alfred Dibao-Dina 博士，美国毒理学委员会认证毒理学家，欧洲注册毒理学家，NAMSA生物安全科学家
Alfred Dibao-Dina博士是经美国毒理学委员会认证并在欧洲注册的毒理学专家，拥有生物医学工程博士学位。自2017年加入NAMSA以来，其专注于依据ISO 10993-1和ISO 14971标准编写及审核生物学评价计划与报告，并依据ISO 10993-17标准开展毒理学风险评估。他定期提供培训，并协助完成NAMSA德国化学实验室的资质认证与验证工作。完整简历请点击此处
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