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TRADESHOW

MDM Minneapolis

October 23, 2019
through
October 24, 2019

Minneapolis, MN

Mike Pizzi
+1 (801) 290-7524
mpizzi@nelsonlabs.com

We are happy to announce Nelson Labs will be exhibiting in booth #2022 with our sister company Sterigenics at the 2019 MDM Minneapolis tradeshow, in Minneapolis, Minnesota, October 23-24, 2019.

Nelson Labs will have consultants available to MDM Minneapolis participants to answer even the most difficult testing and compliance questions. Stop by booth #2022 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’ MDM Minneapolis Events:

 

Tech Theater Lecture (Free)

Topic: Keeping Up With the Rapid Changes in Biocompatibility Regulation

Date:  October 23, 2019

Time: 1:30 PM – 2:15 PM (CST)

Booth: 2509

Presenter: Audrey Turley

Why is biocompatibility such a hot topic? The realm of biocompatibility has had some major changes over the last decade including significant changes in more than five ISO 10993 standards, updated FDA guidance on ISO 10993, and the implementation of the MDR. Topics covered include:

 

  • Highlight of significant changes in the standards over the last decade
  • Specific MDR requirements for biocompatibility
  • FDA guidance on ISO 10993-1
  • Current regulatory expectations and interpretation of changes

 

Conference

Topic: Managing Biocompatibility Risk: Applying the New ISO 10993 Standards
Date:  October 24, 2019
Time: 11:00 AM to 11:45 AM (CST)
Booth: 2022
Presenter: Audrey Turley

Documentation is playing a bigger role in submissions these days and are an important part of ISO 10993-1. Start with a biological evaluation plan (BEP) to identify device risk and identify appropriate mitigation steps (i.e. testing). The BEP and testing culminate information that feeds into a Biological Evaluation Report (BER). To be effective, you must be able to communicate device specific information and the factors influencing your approach to biocompatibility. Topics covered include:

  • 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?