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Biological Safety Training—Boston



Date(s) - October 14, 2024 - October 17, 2024 All Day


Boston Marriott Long Wharf
296 State St
Boston, MA 02109

*** In-person training ***

Course A: Biocompatibility of Medical Devices – Two-Day Certification Course-

Date: October 14-15, 2024
Location: Boston Marriott Long Wharf
Price: $2,150 USD (early registration discount of $1,800 USD ends Sunday, September 1, 2024)

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

Register for both Course A & Course B and save! 

September 14-17, 2024 $3,650 USD (early registration discount of $2,950 USD ends Sunday, September 1, 2024)

NOTE: Our security measures require that your credit card billing address match your profile address.


Course B: Continuing Education for the Biological Safety Specialist

Prerequisite: Course A: Biocompatibility of Medical Devices – Two-Day Certification
Date: October 16-17, 2024
Location: Boston Marriott Long Wharf
Price: $2,150 USD (early registration discount of $1,800 USD ends Sunday, September 1, 2024)

This two-day training course is designed for those who have received certification to the NAMSA Training Series Biocompatibility of Medical Devices – Two-Day Certification Course. Objectives of this course include practice beyond the basics of Table A.1 in ISO 10993, with increased practical application and updated workshops. In addition to traditional medical devices, we will address combination products and resorbable materials. Participants will not only learn how to assess their device for biological risks, but also understand when testing is not necessary.

Utilizing ISO 10993-17, attendees will actively calculate toxicological thresholds with practical chemical characterization data. Additionally, instructors will provide an opportunity to work with real-world medical device case studies  and provide solutions and an understanding of how to present data in a submission during the hands-on workshops. Participants will walk away with the knowledge of how to plan a strategy to endure potential obstacles.

Course Objectives

Upon course completion, attendees will be able to:

  • Distinguish global regulatory expectations for biological safety
  • Review reports for accurate data and understand when to work with a laboratory when unexpected results are reported
  • Evaluate complexities for drug/device combination devices
  • Calculate toxicological thresholds for cancer, chemical mixtures and assessment of unidentified chemicals
  • Apply skills gained from two real-life exercises to calculate toxicological thresholds and experience testing errors and how to mitigate them, as well as manage a device from concept to market clearance


Register for both Course A & Course B and save! 

October 14-17, 2024 $3,650 USD (early registration discount of $2,950 USD ends Sunday, September 1, 2024


NOTE: Our security measures require that your credit card billing address match your profile address.

*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com



NAMSA has secured a limited number of sleeping rooms at the Boston Marriott Long Wharf. Individual reservations can be made by visiting this page.

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Biological Safety Training—Boston

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Don Pohl

Principal Product Development Strategist

Don holds a Bachelor’s degree from Ohio State University and has over 25 years of experience in the preclinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.

Phillip Smiraldo, PhD, DABT

Principal Toxicologist

Phillip holds a PhD in Molecular and Cellular Biology from the University of Toledo Medical Center (formerly Medical College of Ohio) and a BS in Biology from Bowling Green State University (summa cum laude; with minors in Chemistry and Italian Language). He was a Postdoctoral Fellow at the University of Texas Southwestern Medical Center (awarded two grants to support his research), authored several articles that were published in peer-reviewed journals (regarding his research of DNA repair in mammalian cells), and authored a book chapter appearing in Telomerases: Chemistry, Biology, and Clinical Applications, and has provided several oral presentations. Dr. Smiraldo’s timeless experience in the medical device industry encompasses toxicology, biological safety and preclinical study design, as well as extensive preparation of biological and toxicological risk assessments for submission in countries complying with EU and US FDA regulations. Prior to his current position as Toxicologist, he was a Medical Research Scientist and Study Director (NAMSA), overseeing special/custom preclinical functional studies, preclinical safety studies and simulated-use chemistry studies.  Before joining NAMSA, Dr. Smiraldo was a Staff Toxicologist at WIL Research (approximately 2.5 years), where he was a Study Director of preclinical safety studies for pharmaceutical- and chemical-based products.