UL's Anura Fernando will be speaking on the following topic at this month's IEEE PSES meeting.
To be, or not to be…a medical device? Go-to-market strategies for Wearable Tech: Many manufacturers of WT products which were initially introduced into the consumer product market see value in bringing their products into the medical device realm to support the patient benefits of “connected healthcare” and the Medical IoT. Manufacturers making this transition will encounter technical and regulatory challenges ranging from issues such as demonstrating that the performance characteristics of their equipment are suitable for medical applications, to issues of addressing Regulatory Science during pre-market clearance or approval. Other manufacturers may choose to keep their products in “non-medical device” markets. They may still need to consider other aspects of regulation such as OSHA, CPSC, FTC, FCC, etc., in the U.S., as well as EU Directives or other countries’ laws. The gamut of topics to be discussed range from: how to think about designing your product; addressing cybersecurity when the product is in a highly networked environment; dealing with infrastructure such as mobile computing platforms and IT infrastructure that is not within the control of the product developer; etc... We will discuss these and other topics of interest to those manufacturers wishing to make the transition into the medical market, and we will try to provide helpful suggestions for those who wish to steer away from medical device regulations.
Date & Time: April 22, 2015, 7:00pm- 8:00pm
Seimic775 Montague ExpresswayMilpitas, CA 95035Santa Clara, CA 95053