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Date(s) - 04/30/2019
10:00 am - 3:00 pm EST

City Winery


NAMSA invites you to join us at our upcoming event in partnership with MassMEDIC, “Biological Safety of Medical Devices: Updates and Challenges.” Provided throughout this unique conference will be learning opportunities which offer biological safety development strategies, managing regulatory challenges, and the latest innovations and trends reshaping the industry. All sessions will be led by NAMSA’s laboratory testing and biological safety strategy experts as highlighted below.

The day includes not only educational sessions on chemical characterization and the EU Medical Device Regulation (MDR), but will also offer opportunities to network with NAMSA experts and fellow colleagues.


  • The registration fee of $100 includes the full educational program, lunch and beverages.
  • MassMEDIC members will receive a special complimentary discount code to provide this program free-of-charge. Please look for your code, which will be emailed directly from MassMEDIC, in the coming days.

Highlighted during the event will be the following presentations:

ISO 10993-1 2018 Updates: What are the Relevant Changes and How they Impact the Biocompatibility Safety Evaluation Process for Medical Device Manufacturers 
Presented by: Phillip G. Smiraldo, Ph.D., DABT, Medical Research Scientist; NAMSA

Since 2009, the emphasis on a risk management process and characterization of materials continues to shift the biological safety paradigm. Put simply, the days of medical product manufacturers simply contracting with a testing laboratory, and reviewing and accepting a recommended product evaluation plan is no longer a globally accepted practice.

In today’s world, there is continued interest in how an evaluation is conducted long before any biological tests are performed. And, with the release of ISO 10993-1:2018 in August 2018, there is a continued focus on biological safety planning and implementation processes, as well as the characterization of materials. Once again, medical device manufacturers are being asked to go beyond the simple process of identifying a set list of biocompatibility tests when evaluating a device’s biological safety. This informational session will also take a look at the major changes introduced within ISO 10993-1:2018, and discuss how manufacturers can efficaciously prepare for implementation of the new requirements.

Global Regulatory Requirements for Chemical Characterization: How to Cost-Effectively Demonstrate Biological Safety 
Presented by: Phillip G. Smiraldo, Ph.D., DABT, Medical Research Scientist; NAMSA

Medical device organizations that manufacture products that involve patient contact are most often required to perform some level of chemical characterization evaluation, per ISO 10993-18, to ensure end-user safety. Depending on a device’s intended clinical use, chemical characterization – specifically, extractable/leachable testing – may be required by multiple regulatory agencies to address biological safety. However, utilizing this type of testing methodology to address updates to medical devices can prove to be a cost-effective way to assess device changes and their potential impacts to biological safety.

Join this session to learn about global regulatory requirements for chemical characterization testing and how manufacturers can use chemical characterization to demonstrate biological safety for their devices.

EU MDR: MDR General Safety & Performance Requirements for the Biocompatibility of Medical Devices
Presented by: Phillip G. Smiraldo, Ph.D., DABT, Medical Research Scientist; NAMSA

What is the EU MDR and more importantly, is your device technical documentation updated to meet the MDR 2017/745 General Safety and Performance Requirements (GSPRs)? This session will provide best practices and meaningful tips for manufacturers with devices sold under CE marks, and will explain how the MDR supersedes the current EU Medical Device Directive (MDD) 93/42 and 2007/47 requirements as they relate to biocompatibility throughout the full medical device lifecycle.

Also discussed will be information on the specific areas of the MDR that enhance ISO 10993-1:2018, as well as other guidelines that support the  requirements for deeper assessment, reduction and control of biological risk as they relate to patient concerns.

Lastly, critical MDR information will be provided based on NAMSA’s many interactions with EU Notified Bodies and agencies pertaining to the newly expanded requirements.

“New” Testing Methodologies to Minimize Degradation and Maximize Extractable Compounds
Presented by: Angela Sanchez, Principal Chemist, Analytical Services; NAMSA

NAMSA is developing new methodologies to identify and utilize the most efficient  extraction vehicles to maximize relevant extractable compounds while minimizing degradation. This method provides extracts compatible with analytical instruments and leaves the polymer structure unchanged. While no technique currently available can detect all compounds with high accuracy and precision, the use of two independent techniques can detect a greater range of compounds and therefore, provide a value added approach to chemical characterization.

UPLC-MS has become the tool of choice for the detection of nonvolatile compounds for its efficient ability to confirm molecular weight and structure identification. As such, this analytical technique has been employed in the analysis of medical devices. NAMSA’s teams of experts will provide information on instrument-specific methods for Ultra-Performance Liquid Chromatography-Mass Spectrometry (UPLC-MS)

Panel Discussion: Biological Safety Q&A
Presented by: NAMSA Experts
This session will allow attendees to ask questions of the day’s presenters and to share any insights or observations related to efficient biological safety strategies and testing.

Panelists Include: 

Phillip G. Smiraldo, Ph.D., DABT, Medical Research Scientist
Dr. Smiraldo’s experience in the medical device industry encompasses toxicology, biological safety and preclinical study design, and includes extensive preparation of biological and toxicological risk assessments for submission in countries complying with EU and U.S. FDA regulations. Prior to his current position as Medical Research Scientist, he was a Study Director (NAMSA), overseeing special/custom preclinical functional studies, preclinical safety studies and simulated-use chemistry studies. Prior to joining NAMSA, Dr. Smiraldo was a Staff Toxicologist at WIL Research, where he was a Study Director of preclinical safety studies for pharmaceutical and chemical-based products.

He 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), has authored several articles that were published in peer-reviewed journals and book chapters appearing in Telomerases: Chemistry, Biology, and Clinical Applications.

Angela Sanchez, Principal Chemist, Analytical Services

Angela Sanchez’s work focuses on medical device extractables. She specifically leads the mass spectral analysis of chemically characterized medical devices. Prior to NAMSA, she worked as a synthetic organic chemist in the field of RNA interference for greater than ten years, and served as a Technical Director and Senior Scientist at leading CROs. Angela received her Bachelor’s of Science at Wayne State University and went on to graduate school at Colorado State University. She has over 18 years of chemistry experience.

Event Details

Reservations are closed for this event.