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Biocompatibility Testing for Medical Devices  

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Seminar Summary:

Attendees will understand and apply ISO 10993-1 and the FDA Guidance on its use. They will know how to use the ISO documents to locate information that you need. Understand what tests to select and how to choose among various options. (see full course description)

 

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Training Course Syllabus:


Course Description

The medical device field is one of the most heavily regulated industries, for obvious reasons. Medical devices are an important tool in efforts to improve patient care and treatment outcomes. Learn how to achieve more successful biocompatibility testing outcomes by attending this seminar.

Biocompatibility testing is in the spotlight with regulatory bodies – especially with the recent release of the updated European MDRs and the FDA’s Guidance document on ISO 10993-1. It is essential for medical device manufacturers to have an understanding of the current landscape for biocompatibility testing while keeping an eye on the future trends that will affect future requirements. This seminar will discuss the recent changes to regulatory documents and standards and how they will impact the overall biocompatibility assessment of medical devices.

Attendees will understand and apply ISO 10993-1 and the FDA Guidance on its use. They will know how to use the ISO documents to locate information that you need. Understand what tests to select and how to choose among various options.

By attending this seminar, attendees will get answers of these questions:

When is testing not the only option?
Understand how to apply Materials characterization, and more importantly learn how to use the information to understand biological safety?
Understand ISO 14971 and how to use it?
Learn how to use ISO 10993-1 as a tool for hazard identification?
Learn how to develop a program that guides your device on the regulatory path and reduces your time to market?
Practice how to execute your plan from development to completion and how to schedule and document the implementation of your biocompatibility plan.?

Learning Objectives:

After completing this seminar, participants should be familiar with the full scope of ISO 10993-1, including the current version. The topics covered will include:

Gain a deeper understanding of global regulatory expectations for biological safety.
Know how to review reports for accurate data and work with a laboratory when unexpected results are reported.
Understand evaluating complexities for drug/device combination devices.
Familiarization with calculating allowable limits for cancer, chemical mixtures, and assessment of unidentified chemicals.
Experience working application with real life examples to calculate allowable limits, experience testing errors and how to mitigate them, and then manage a device from concept to market clearance.
Gain knowledge on the principles of toxicology, FDA consensus standards, and Good Laboratory Practices.
Learn the difference between evaluation and testing. Recognize when testing is absolutely necessary and how to avoid unnecessary test-ing.

Areas Covered :

The areas that will be discussed in the seminar will include the following topics throughout the agenda:

History of ISO 19993-1
Overview of collateral standards, i.e., 10993-X
Risk based approach (for Biocompatibility)
Review of ISO 14971 Risk management file
Biocompatibility evaluation endpoints
Endpoint assessment vs. testing
Endpoint consideration: Test specific
Chemical testing: Extractables and Leachables
Toxicology assessment

Seminar Summary:

Attendees will understand and apply ISO 10993-1 and the FDA Guidance on its use. They will know how to use the ISO documents to locate information that you need. Understand what tests to select and how to choose among various options. (see full course description)

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