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Biocompatibility Testing for Medical Devices Training & Workshop

Event

May 3, 2023 - May 4, 2023

Price

$800.00 per person.

Location

Salt Lake City, Utah

Contact Information

Mike Pizzi
+1 (801) 290-7524
[email protected]


Learn how to achieve more successful biocompatibility testing outcomes by attending our Biocompatibility Testing for Medical Devices seminar in Salt Lake City, Utah, on May 3rd and 4th. Join biocompatibility experts from Nelson Labs as they share valuable biocompatibility risk-assessment knowledge in a new hands-on training and workshop.

Biocompatibility testing is in the spotlight within the medical device industry due to a rapidly changing landscape, as critical components of the ISO 10993 standard series are being updated and revised. It is crucial for medical device manufacturers to understand the current landscape for biocompatibility requirements, while keeping an eye on trends that will impact the near future. Current challenges in the market are also driving the need to be able to critically evaluate device changes to ensure devices can stay on the market and be supplied without delay.

Learn how to successfully apply a biocompatibility risk-based approach per ISO 10993-1 to medical devices and determine approaches to meet current regulatory requirements. The workshop will walk you through the process of creating a biological evaluation plan (BEP), determining the correct sample to test, evaluating results, dealing with failures, generating a biological evaluation report (BER), and successfully answering common regulatory-agency questions and concerns. In the second day of the workshop the concepts discussed during the first day will be applied to actual scenarios to ensure that participants walk away from the event with a clear understanding of important concepts.

This event will also provide participants with the following opportunities:

  • Open discussion amongst industry peers
  • Interaction with Nelson Labs testing experts
  • Industry networking
  • Regulatory feedback

Learn more about some of our industry experts presenting at this seminar: Thor Rollins, Audrey Turley, and Janelle Lauer.


Wednesday, May 3, 2023

Having a solid biological evaluation plan (BEP) and a full biological evaluation report (BER) can make all the difference for submission success. We will have the time to take a deep dive into the most critical components, such as device description and categorization, justification of the approach to the physical- and chemical-information requirements, sample preparation details, discussion of test failures, and management of device changes. Be ready for great discussions, examples, and risk-assessment strategy that will keep you engaged and informed.

The following topics will be covered in day one:

  • Introduction to Biocompatibility and to Risk Assessment
  • Device Categorization: Why Device Descriptions Are Critical
  • How to Meet the Physical/Chemical Information Requirement for Every Device
  • What is Extractables & Leachables Test and How to Use the Data
  • Sample Preparation: Details that Manufactures Should Know
  • Biocompatibility Testing Review and Discussion (Including Failures)
  • Formulating Risk Assessments (Including BEPs, CAPAs, and BERs)
  • Maintain Regulatory Relationships During a Submission: Tips to Have Successful Conversations When Disagreements Arise

Thursday, May 4, 2023 – Hands on Workshop

On day two you can test your knowledge. This is a unique opportunity to try out your risk-assessment skills with a group of industry peers and experts. Write a BEP and formulate a biological evaluation report (BER) based on a case study (to be provided). You will receive expert feedback so that when the real submission time comes, you will be ready and ahead of the game.

The following topics will be covered in day two:

  • Samples Distributed for the Projects: Explanation of Intended Use
    • Teams will be given real-life examples of medical devices and will understand their intended use and risk
  • Formulate Your Biological Evaluation Plan (BEP)
    • Using your team, formulate a BEP for your subject device
  • Sample Preparation Considerations
  • Test Result Determination and Failure Investigation
  • Formulate your Biological Evaluation Report (BER)
  • Receive Regulatory Feedback
  • Assessing Device and/or Standard Changes

Registration Details:

The deadline for all registrations is April 21, 2023.

Groups of three or more may contact Mike Pizzi at [email protected] or +1 (801) 290-7524 for discounted pricing information.

Hotel Accommodations:

Guests planning to stay on location may refer to our suggested list of nearby hotels. Nelson Labs has no current affiliation or partnership with these hotels.

Please note that the registration fee does not include hotel accommodations.

Other Details:

Lunch and refreshments will be served daily and are included in the seminar package.

Seminar Cancellation Policy