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MD&M East 2019

June 11, 2019
June 13, 2019

New York, New York

Mike Pizzi
+1 (801) 290-7524

We are happy to announce Nelson Labs will be exhibiting in booth #1739 at the 2019 MD&M East tradeshow, in New York, New York, June 11-13, 2019.

Nelson Labs will have consultants available to MD&M participants to answer even the most difficult testing and compliance questions. Stop by booth #1739 for a complimentary personalized 30 minute consultation, and mark your calendar for Nelson Labs’ educational lectures, and roundtable debate (additional details provided below).

Nelson Laboratories’ MD&M East Events:

Tech Theater Lecture (Free)

Topic: The New “Big Three” biocompatibility in vitro alternatives are at our door
Date:  June 11, 2019
Time: 1:30 PM
Presenter: Thor Rollins, Director of Toxicology and E&L Consulting

Half Day Seminar Track (Free)

Topics: Biological Safety Evaluation: Using a Risk-Based Approach for Biocompatibility
Date: June 12, 2019
Time: 10:30 AM to 1:30 PM
Presenters: Thor Rollins, Director of Toxicology and E&L Consulting

See below for the view the full agenda.

This seminar summarizes how biocompatibility of medical devices is evaluated from a risk-based approach, based on the most recent feedback from FDA. The presentation focuses on the aspects most relevant to anyone who may influence the design, engineering, and quality assurance of devices. An introduction is given to the ISO 10993 standards and FDA guidance documents for medical devices as they apply to medical device manufactures. Focus is given to:

  • Biocompatibility risk analysis
  • How to use the risk analysis results for biocompatibility
  • FDA trends in approaches to biocompatibility testing
  • How chemistry is being used as an approach to biocompatibility
  • How to evaluate the impact of changes to biocompatibility

Understanding biocompatibility and associated testing is essential to all involved in the development and manufacture of medical devices. Issues that can be challenging for a final, finished device from a biocompatibility perspective may be easily prevented. Part of this seminar is in lecture format, while part is comprised of interactive, hands-on case studies.

10:30-11:30 am
Part 1- ISO 10993-1 Biocompatibility (Applying the New ISO 10993 Standards)
Speaker: Thor Rollins, Director, Toxicology & E&L Consulting, Nelson Labs, LLC

  • An overview of the new ISO 10993-1
  • Performing a Biological Evaluation Plan
  • Overview of the “Big Three” including new in vitro alternatives
  • What is needed in a Biological Evaluation Report for the FDA?

11:30-1:00 pm
Part 2- ISO 10993-18 What is E&L and How to Evaluate Changes to Medical Devices
Speaker: Thor Rollins, Director of Toxicology and E&L Consulting

  • What is the current regulatory status of extractable & leachable testing?
  • How can we make sure the regulatory bodies will accept our E&L studies?
  • If  a material is changed, how is safety impacted?
  • If the change is small, is do you need to retest?
  • What if I change a manufacturing process, do you need to retest?

1:00 -1:30 pm
Part 3- MDRs Riding out the Storm
Speaker: Thor Rollins, Director of Toxicology and E&L Consulting

  • What changes do the MDR bring and how much time do I have to comply?
  • Will Brexit impact my European submission?
  • What will my Notified Body be looking for with regard to the MDR?
  • Case study regarding different approaches

Medtech Education Hub

Topic: How’s Your Device Classification Skills? Hands-On Practice That Will Improve Your Expertise
Date: June 12, 2019
Time: 3:00 PM to 3:45 PM
Location: Booth 1669
Presenters: Thor Rollins, Director, Toxicology & E&L Consulting, Nelson Labs, LLC

Join ISO 10993 expert Thor Rollins as he leads you through a hands-on opportunity to test and polish your skills. Biocompatibility is a key component of many devices today, due to the nature of their use and contact with the body. You’ll get an opportunity to practice categorizing devices through a hands-on sample preparation discussion, demonstrating that you know (or don’t!) when to use coupons and how to represent a final device. See if your skills match up to FDA’s requirements. How good is your expertise?

About MD&M East: Delve into the latest challenges and opportunities that are impacting medical device design & manufacturing with the 2019 MD&M East Conference. Hear from the industry’s brightest and gain valuable insights that will help you overcome the most crucial challenges from concept to market. Build your knowledge and your network at this annual industry gathering.