Software as a Medical Device- July 2021

RAC Credits
Online Workshop
Tuesday, 27 July 2021 (9:00 AM) - Wednesday, 28 July 2021 (4:00 PM) Eastern Time (US & Canada)

Navigating the expectations for software products is particularly challenging and requires a different approach from other medical devices. Join us for a review of the current and evolving global regulatory requirements affecting software as a medical device (SaMD). Our expert faculty will address both how to determine when software is considered regulated as SaMD and how to determine correct class/classifications under global requirements. Since performing risk management/assessment for software is generally more challenging, attendees will work through completing required evaluations using practical case studies.


18 December 2020 – 27 June 2021: Early Bird $800 Members | $900 Nonmembers

28 June – 20 July 2021: Regular $900 Members | $1,000 Nonmembers



Day 1

·        The Development of SaMD – Past, Present, Future: A Global Timeline of SaMD Guidance Documents and Regulations                            

·        SaMD vs SiMD – Definition, Classification, and Variations                              

·        The Cybersecurity, Privacy and Inter-Operability Issues with SaMD and Digital Health           

·        21st Century Cures – The Regulatory Oversight Framework for SaMD and Digital Health


Day 2

·        FDA Pre-Certification Program

·        How to Apply Various Standards & Guidance Documents

·        Software Guidance Documents & Standards Across the Globe

·        Creating a Strategy for Software as a Medical Device

·        Global Regulatory Considerations for SaMD

·        Clinical Decision Support Software

·        Classification Use Case Studies



Lena Cordie Bancroft, Qualitas Professional Services
Lena Cordie-Bancroft is the president and principal consultant at Qualitas Professional Services, where she works with medical device, dental and IVD companies to implement ISO 13485 and FDA QS Regulation compliant quality management systems; incorporate processes to comply with FDA, EU and other international regulatory requirements related to quality systems, risk management; and regulatory compliance related to labelling and Unique Device Identification (UDI) requirements. She is a member of AAMI Sterilization Standards, ISO/TC 198 and ISO/TC 210 work groups. She is a member of ASQ, and as a member of Regulatory Affairs Professionals Society (RAPS), serves as the chairperson for the Twin Cities Chapter, is a member of the RAPS European Committee (REC), and a leader of the UK Local Networking Group.

Michelle Jump, Medical Device Security, MedSec
Michelle Jump is the Global Regulatory Advisor, Medical Device Cybersecurity at MedSec, where she is responsible for providing strategic leadership, training and advisory services to the medical device industry in the area of cybersecurity compliance, global regulations, standards, product security program development, and security risk management.

Pat Baird, Philips
Pat Baird works at Philips as the head of global software standards. Pat likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and  developers, and developing standards, whitepapers, and training to meet those needs. He co-chairs the AdvaMed software committee and an AAMI committee on agile software development. His current passion is related to artificial intelligence in healthcare; he is the convenor or co-chair in several AI committees, including ISO/IEC TC215 AHG2 standards regarding AI in healthcare, MITA trade association, CTA trade association, Xavier University, World Health Organization, and is an industry representative on a newly formed IMDRF AI committee.

Atbin Rad Global Director Functional safety software and digitization bei TÜV SÜD
As the director for digitization, Rad is responsible for TÜV SÜD’s activities around medical device software, artificial intelligence, and cybersecurity. He is member of the standardization committee for medical device IT security (60601-4-5), and he has coauthored the guidance document for cybersecurity provided by the interest group of notified bodies. Rad has 14 years of professional experience in the development of medical device software. He has worked as a software- and IT-focused certification auditor and served as an associate professor at the University of Applied Sciences and Technische Universität Ilmenau on the topics of medical device software, medical imaging and digital filter design.


Proof of Attendance

An electronic letter of attendance will be sent upon request.


Cancellation Policy

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 via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title.

Substitutions may be accepted with written approval from RAPS and must be submitted to

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at