We plan to webcast the Class of 2015 MSOE biomedical engineering junior design project presentations live from 5:00 to 7:30 pm CST (GMT -6) on Thursday, December 12, 2013. See them at: http://www.ustream.tv/channel/msoe-biomedical-engineering-program. If all goes well, the presentations will also be recorded for later viewing. Note that this is an experiment, so we will be using the annoying ad supported version of ustream.tv.

Project Topics are:

• Plasma (Blood) Glucose Monitoring System

• Neonate Cardiopulmonary Bypass Simulator

• In utero Spinal Bifida Cystica Repair System

• Knee Joint Ultrasound Phantom

• Total Knee Replacement Surgical Aid

• Feedback System for Competitive Rowers

• Head Injury Research Device

An after dinner keynote presentation by MSOE BE program alumnus Brian R. Biersach, President and Senior Biomedical Engineer at Medical Equipment Compliance Associates, LLC will be also be webcast starting at around 8:10 pm.

This event is sponsored by MSOE and the Milwaukee Section of IEEE.

Please forward this message to others you think might be interested. I will be tracking the number of viewers to determine if these webcasts are worthwhile.

Charles Tritt

FDA CDRH Priority List

Posted by Charles Tritt Dec 5, 2013

The Center for Devices and Radiologic Health (CDRH) is the part of the FDA that deals with medical device regulations. As part of a new law, they will now annually publish a list of their priorities for the coming year. The complete  2014 list can be found at:

CDRH Fiscal Year 2014 (FY 2014) Proposed Guidance Development

Biomedical engineers should be aware of the items on this. Here are some highlights that I noticed:

Final Guidance Topics

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

The Pre-Submission Program and Meetings with FDA Staff

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications

Types of Communication During the Review of Medical Device Submissions

Applying Human Factors and Usability Engineering to Optimize Medical Device Design

Global Unique Device Identification Database

Design Considerations for Pivotal Clinical Investigations for Medical Devices

Draft Guidance Topics

Benefit-Risk Determinations in Premarket Notifications (510(k)s)

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

Custom Devices

Hearing Aids and Personal Sound Amplification Products (PSAPs)

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