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Description
In-person training in English – Course A only
Course A: Biocompatibility of Medical Devices
Two-Day Certification Course
Date: September 8-9, 2025
Location: Marriott Hotel City Center
Price: $2,150 USD (early registration discount of $1,800 USD ends Sunday, July 27, 2025)
Agenda: Course-A-Agenda-Minneapolis-2025 (Monday reception: reception with appetizers, networking with attendees and speakers)
The release of ISO 10993-1:2018, 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 10993-1:2018 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
- Prepare to 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
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.
Phillip Smiraldo, PhD, DABT, Principal Toxicologist, NAMSA
Phil is a Principal Toxicologist in the Biological Safety Department at NAMSA. His experiences in the medical device field encompass toxicology, biological safety, preclinical study design, and extensive preparation of biological and toxicological risk assessments. Prior to his role, he was a Study Director overseeing special/custom preclinical functional studies, preclinical safety studies, and simulated-use chemistry studies.
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