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Biocompatibility Testing of Medical Devices in the US and Use of ISO-10993 - Webinar by GlobalCompliancePanel
This Webinar is over| Date | Mar 26, 2014 |
| Time | 01:00 PM EDT |
| Cost | $225.00 |
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Online
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Overview:
Biocompatibility testing is an essential and critical component of any US marketing application for a medical device that has direct or indirect contact with humans. This webinar will cover the FDA's existing and recently updated draft guidance on the use of ISO-10993 to determine what testing is necessary, and describe in detail general and specific testing considerations, based on the nature and duration of contact of the medical device with humans. It will also cover when animal safety studies may be used to justify omission of certain biocompatibility tests, as well as the desired content of a biocompatibility test report.
Why should you Attend:
You should attend because biocompatibility testing is an essential and critical component of any US marketing application for a medical device that has direct or indirect contact with humans. Therefore, it is important to know how to use the available FDA guidance to determine which tests listed in ISO-10993 will be required based on the nature and duration of contact of the medical device with humans. It is also important to know and understand specific details regarding how testing should be conducted in order to meet FDA's expectations.
Areas Covered in the Session:
Who Will Benefit:
Elisa Harvey is a Senior Regulatory Consultant at CardioMed Device Consultants. She provides clinical, preclinical and regulatory consulting services for the medical device industry. Dr. Harvey brings extensive scientific and regulatory experience to assist at every step of the device development plan from early animal testing to clinical trial planning and regulatory submission strategy.
Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Biocompatibility testing is an essential and critical component of any US marketing application for a medical device that has direct or indirect contact with humans. This webinar will cover the FDA's existing and recently updated draft guidance on the use of ISO-10993 to determine what testing is necessary, and describe in detail general and specific testing considerations, based on the nature and duration of contact of the medical device with humans. It will also cover when animal safety studies may be used to justify omission of certain biocompatibility tests, as well as the desired content of a biocompatibility test report.
Why should you Attend:
You should attend because biocompatibility testing is an essential and critical component of any US marketing application for a medical device that has direct or indirect contact with humans. Therefore, it is important to know how to use the available FDA guidance to determine which tests listed in ISO-10993 will be required based on the nature and duration of contact of the medical device with humans. It is also important to know and understand specific details regarding how testing should be conducted in order to meet FDA's expectations.
Areas Covered in the Session:
- History and background of biocompatibility testing and ISO-10993
- Previous FDA guidance
- Current FDA draft guidance
- Test selection
- General testing considerations
- Specific testing considerations
- Use of animal safety studies to justify omission of specific biocompatibility tests
- Assessment of known and/or potentially toxic chemical entities
- Contents of a biocompatibility test report
Who Will Benefit:
- Regulatory affairs professionals
- Compliance Managers
- Quality Managers
- Manufacturing Engineers
- Research and Development
Elisa Harvey is a Senior Regulatory Consultant at CardioMed Device Consultants. She provides clinical, preclinical and regulatory consulting services for the medical device industry. Dr. Harvey brings extensive scientific and regulatory experience to assist at every step of the device development plan from early animal testing to clinical trial planning and regulatory submission strategy.
Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
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