San Francisco Bay Area Chapter: Wellness Device or Medical Device?

In this module, we will discuss the difference between a medical device and a wellness device. We will explain the importance of the manufacturer’s claims about the product and how this can impact the classification.

Also included in the discussion:

• Testing assurance using standards
• Medical equipment 60601 series of standards
• Health and hygiene wearables
• Information technology wearables
• Certification
• Biocompatibility/toxicity
• Human factors/usability
• Testing assurance to support claims
• Accuracy of measurement, number of steps, distance, laps
• Environmental claims
• Durability
• Custom

Registration Fees

$0 Member | $25 NonMember

Learning Objectives

Participants will be able to:

• Differentiate between a medical device and a wellness device
• Understand human factors/usability entailing to regulatory requirements for medical devices
• Understand FDA’s testing assurance standards

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Who Should Attend?

• Global regulatory affairs professionals
• Regulatory affairs managers and specialists
• Medical Device specialists

Speakers:

Paul Hilgeman
Global Director and Industry Leader for Medical, UL Solutions

Paul has been with UL over 15 years, most of the time spent in the medical device safety certification business, with some time spent in consumer technology.

Cancellations

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.