The current medical device Quality Management System (QMS) standard ISO 13485: 2016 does not address the specific requirements of a cyber device. In this session, we intend to answer the question that whether the current QMS standard, which is applicable to all medical devices, is sufficient to be in compliance with FDA cybersecurity guidelines from a QMS perspective. If yes, under which clauses would the cybersecurity guidelines fall? This workshop will address what the other specific standards are to which compliance is necessary to meet FDA cyber device requirements. We will consider the bar set by FDA on cyber device scrutiny in review and also legal amendments to the governing act enabling a rejection in lieu of cybersecurity concerns which was earlier limited to safety and effectiveness.
Learning Objectives
- Upon completion, participant will be able to adequately understand whether compliance to which standard and specific clauses are necessary for meeting FDA cybersecurity guidelines.
- Upon completion, participant will be able to adequately understand whether the current QMS standard is equipped to deal with cyber devices.
- Upon completion, participant will be able to have a fair understanding of the likely harmonization considerations in the majority regions on cybersecurity.
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.
Cancellations and Refunds
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 [email protected].Cancellations will receive a full refund minus a 20% administrative fee.RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected]with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
