RAPS Workshop: The Future of Wearable Medical Devices: A Regulatory Perspective
Virtual Programs 
Wearable medical devices sit at the intersection of rapidly evolving technology and healthcare.
At this interactive virtual workshop, you will develop a deeper understanding of the different types of wearable devices, from fitness trackers to complex medical-grade devices, and how these innovations are shaping the future of patient care and health monitoring.You will learn about the regulatory landscape that governs wearable medical devices, including the critical requirements for FDA approval and global standards such as ISO 13485. This knowledge will help you and your organization ensure your devices meet safety, efficacy, and compliance standards, positioning them for successful market entry.
You will also explore key aspects of design, development, and data security, all of which are crucial for creating wearables that are both user-friendly and clinically reliable. The workshop will provide practical insights into integrating advanced technologies, such as sensors and AI, while addressing challenges like data privacy and cybersecurity.
Registration Fees & Deadlines
Present - 19 August 2025: Early Bird Member $205 | Nonmember $240
20 August 2025 - 19 September 2025: Regular Member $240 | Nonmember $285
Learning Objectives
- Upon completion, the participants will be able to understand the regulatory requirements for wearables as medical devices.
- Upon completion, the participants will be able to understand the design and development best practices for wearables.
- Upon completion, the participants will be able to understand how to navigate market access mainly in US and EU
Who Should Attend?
Regulatory Affairs Professionals, Project Managers, Quality 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.
Speakers
Ritam Priya, MBA
Head of Medical Devices, RA, Meta
Ritam Priya, is a seasoned medtech leader with over 15 years of experience in the medical device and digital health industries. She has worked for companies like Baxter Healthcare and Johnson & Johnson. Ritam enjoys working on innovative medical products and some of her most recent experience has been with digital health startup companies like Eko Devices, Beddr (now Oura), Nocimed (now Aclarion) and Aktiia, where she has successfully led the quality and regulatory team. She has extensive experience in global medical device and digital health sectors, including AI/ML. Her expertise spans regulatory pathway development, regulatory submissions, regulatory intelligence, project/program management, post-market surveillance, quality assurance, quality control, new product engineering, and clinical strategy. She has successfully led over 50 regulatory authorizations and market registration for innovative and novel products around the globe.
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.
