IFAI Expo 2019
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Regulatory and Device Evaluation Challenges for Textile Biomaterial Devices
(
Room
S210A
)
01 Oct 19
1:00 PM
-
1:50 PM
Tracks:
Advanced Textiles Conference, Short Courses
Speaker(s):
Elaine Duncan, MSME, RAC, AIMBE, President, Paladin Medical Inc.
Textile medical devices are facing challenges on sufficient testing of materials and devices before commercialization. These challenges are changing the regulatory pathway to market. Meanwhile, global upheaval in what was perceived as the regulatory pathway to market has raised the anxiety and costs of putting a new medical textile into the market. Attendees will learn about how a wellfounded strategy for qualifying the medical textile is crucial to success.
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