RAPS Workshop: Safety Engineering for Regulatory Excellence in Medical Product Development

Safety engineering is a systems engineering discipline that ensures engineered systems provide acceptable levels of safety. In the context of medical products, safety engineering ensures that a product performs its intended functions safely while delivering clinical benefits. Without a solid understanding of safety engineering, the focus can shift away from ensuring safety, leading to unsafe devices and delays or increased costs in product development and lifecycle maintenance. Mastering safety engineering, on the other hand, allows for the proactive integration of safety and effectiveness from the concept phase through design and throughout the product's lifecycle. This approach results in safer products, streamlined development processes, reduced costs, and enhanced compliance, all of which foster innovation.

This workshop will teach the key principles and tools of safety engineering and demonstrate how they can be applied in product development, risk management, regulatory submissions, and lifecycle management. Through practical examples, the workshop will explore the applications and benefits of safety engineering, with a special focus on emerging and innovative technologies such as smart and autonomous medical systems (SaAMS), AI-powered medical applications, and complex drug-device combination products, where the regulatory framework is either lacking or continuously evolving

By applying safety engineering principles early on, manufacturers can identify and address new risks, ensuring safety and effectiveness even when regulations are still developing. This proactive approach drives innovation and ensures that medical technologies are safely introduced to the market, meeting both regulatory expectations and clinical needs.

Registration Fees & Deadlines

Learning Objectives

• Embed safety engineering from concept development to post-market surveillance.
• Address emerging risks related to AI, autonomous devices, and drug-device combinations, while navigating evolving regulatory frameworks.
• Develop proactive safety strategies aligned with QbD principles, ensuring safety is engineered from the start.
• Streamline regulatory submissions by applying holistic safety engineering practices to integrate design controls, risk management, QbD, and post-market surveillance.
• Adapt to current and future regulatory requirements, using insights to anticipate challenges and refine safety engineering practices.

Who Should Attend?

• Regulatory Affairs Professionals
• Quality Managers
• Compliance Managers

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Agenda

Day 1

Welcome and Introductions

The Myth About Safety

• Safety vs. Effectiveness
• Safety vs. Risk Management
• Safety vs. Cybersecurity
• Safety vs. Reliability
• Safety vs. Manufacturability
• Safety vs. Compliance
• Regulatory Challenges in Safety Demonstration and Evaluation

Break
Introduction to Safety Engineering

• Introduction to Safety Assurance Case Method
• Applications of Safety Assurance Cases
• Learnings from Practicing Safety Assurance Case Method
• What is Safety Engineering

Day 2

Integration of Safety Engineering in Product Development
Safety Engineering in Design Controls

• Safety Engineering in Pharma Quality by Design (QbD)
• Safety Engineering in Risk Management
• Safety Engineering in Cybersecurity
• Safety Engineering in Reliability
• Safety Engineering in Manufacturing Process Controls
• Safety Engineering in Quality Systems Compliance
• Safety Assurance Case Development

Break
Exploring Safety Engineering for Emerging/Complex Medical Technologies

• Safety Engineering for a Remotely Controllable Medical System
• Safety Engineering for an AI-Empowered Medical Application
• Safety Engineering for a Complex Drug-Device Combination Product System

Benefits of Safety Engineering in Regulatory Excellence
Adjourn

Speakers

Fubin Wu, MS 

James Wabby BSc., MHMS

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 support@raps.org. 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 support@raps.org 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