Learn how to achieve more successful biocompatibility testing outcomes by attending Nelson Laboratories’ Biocompatibility Testing for Medical Devices seminar in Philadelphia, PA.
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.
Join Nelson Labs biocompatibility experts as we share our 30+ years of biocompatibility risk assessment knowledge in a new, hands-on, two-day workshop. 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 walks 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. The second day of the workshop will apply the concepts from day one to real life medical devices to cement learning.
This interactive, educational two-day training will also allow for open discussion with industry peers, interaction with Nelson’s testing experts, attendee networking and regulatory feedback. Our industry expert speakers presenting at this seminar include Thor Rollins, Audrey Turley, and Jannelle Lauer. This is subject to change.
To learn more about the seminar schedule, access the agenda.
Wednesday, October 26, 2022
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, justifying the approach to the physical/chemical information requirement, important sample preparation details, discussing test failures, and how to hand device changes. Be ready for great discussions, examples, and risk assessment strategy that will keep you engaged and informed.
Topics covered will include:
- 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, Caps, and BERs)
- Maintain Regulatory Relationships During a Submission – Tips to Have Successful Conversations When Disagreements Arise
Thursday, October 27, 2022 – Hands on Workshop
Test your knowledge! This is a unique opportunity to try out your risk assessment skills amongst a group of industry peers and experts. Write a BEP and formulate a biological evaluation report (BER) based on a case study that will be provided. Hear the feedback now so that when submission time comes, you are ready and ahead of the game.
Topics covered will include:
- Samples Distributed for the Projects – Explanation of Intended Use
- Teams will be given real life examples of medical devices an 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 for both days is $800 per person.
Registration deadline is October 14, 2022.
Lunch and refreshments will be served daily and are included in the seminar package. The registration fee does not include hotel accommodations.
Guests planning to stay on location can coordinate their hotel reservation online. A negotiated rate of $169.00 per night has been arranged with Hilton Philadelphia City Avenue. Reserve your room at this rate. This offer is good until October 3, 2022, or until rooms are sold out.
Group Event Registration:
Groups of three or more may contact Mike Pizzi at firstname.lastname@example.org or +1 (801) 290-7524 for discounted pricing information.