Events

 Rocky Mountain Regulatory Affairs Society 
presents

Webinar Series
SDLC and Cybersecurity/Security Risk Management for Medical Device Software
October 15, 2026 and November 11, 2026

12:00 pm - 1:00 p m

October 15, 2026

Software Development Life Cycle (SDLC) for Medical Device Software:
A Beginner’s Introduction
Beginner-friendly one-hour webinar provides an introduction to the Software Development Life Cycle (SDLC) used for medical device software in order to meet regulatory requirements.

Participants will learn

• Why medical device software is different from conventional software
• How regulatory requirements and industry standards influence development activities
• How software moves from initial requirements through design, testing, release, and maintenance.

 Key concepts

• Software safety classification
• Risk management
• Traceability
• Cybersecurity
• Post-market monitoring
• Roles played by Development, Quality, Regulatory, and Leadership

Designed for cross-functional personnel with little or no prior SDLC experience, this session provides a practical foundation for understanding how medical device software is developed safely, effectively, and in compliance with regulatory expectations.

November 11, 2026
Cybersecurity/Security Risk Management for Medical Device Software:
A Beginner’s Introduction
Beginner-friendly one-hour webinar provides a clear introduction to the Security Risk Management process used for medical device software in order to meet regulatory requirements.

Participants will learn

• Why Security Risk Management is different from safety Risk Management (e.g. ISO 14971),
• How to implement and execute security Risk Management throughout the SDLC.

 Key concepts

• Interaction of safety and security risk management processes throughout the throughout the SDLC, Roles played by Development, Quality, Regulatory, and Leadership

Designed for cross-functional personnel with little or no prior SDLC or Security Risk Management experience, this session provides a practical foundation for understanding how Security Risk Management is applied to medical device software effectively, and in compliance with regulatory expectations.

SPEAKER

Jeff Dupont - President & Chief Executive Officer –

Covita Health Partners
Jeff brings experience across three decades in Quality, Compliance, and Operations across the full product lifecycle, from research and development through postmarket activities. He has supported a wide range of organizations, from early-stage startups to Fortune 50 companies, within the medical device, tissue, and combination product industries.

Jeff is highly experienced in design and development, product launches, compliance strategy, and remediation. His collaborative work spans functions including R&D, regulatory, marketing, sales, legal, operations, manufacturing, and supply chain, giving him a comprehensive understanding of cross-functional alignment.

His expertise includes developing and executing quality and compliance strategies in key areas such as quality systems, regulatory engagement, software, combination products, design controls, and risk management. He also has deep experience in design and process verification and validation (including cleaning and sterilization), CAPA, supplier qualification and management, complaint handling and reporting, organizational effectiveness, and both technical and leadership development. Additionally, Jeff has led the start-up and ongoing operations of multiple medical device manufacturing facilities in both domestic and international settings.

To register, go to programs@rmras.orgprograms@rmras.org and indicate which webinars you wish to attend. Details on how to sign in to the webinars will be sent upon registration.
 

For questions or additional information, contact Nan Matthews, programs@rmras.org