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What Medical Device Software to Develop Under QMS

The line between the device and non-device components of medical device software can sometimes seem blurry. Making the wrong choice to not develop a software module under design controls may lead to expensive, time-consuming rework.

How do you decide which parts of your device fall under your QMS umbrella, and which don’t? And how do you account for changes to your device during development as well as its potential changes in the future?

With good planning and forethought, you can lay the groundwork for a strategy that evolves with your device, keeps development on track and prepares you for any way the wind may blow.

Join Orthogonal on February 2nd, 2024 at 12 PM EST as we tackle the challenge of determining when to develop software under design controls. You’ll hear from expert speakers who have solved this challenge for businesses of all sizes, including venture-backed startups and Fortune 500 MedTech firms.

You’ll leave this webinar with:

  • Examples of the complex scenarios that blur the line between device and non-device components of medical device software.
  • Actionable steps you can take in the early stages of device design to meet the challenges of a shifting regulatory environment and avoid future rework and overruns on budgets and schedules.
  • Strategies that deftly align medical device software regulatory needs with modern software development practices to minimize accrual of technical, quality and regulatory debt.


Clay Anselmo

Clay Anselmo

Clay Anselmo, Principal Quality and Regulatory Consultant, Shriner and Associates

Clay is an internationally recognized regulatory compliance expert with an unmatched track record in resolving pre- and post-market quality and regulatory compliance issues. Clay has provided strategic input and direction and led complex quality-related projects for hundreds of medical device companies facing regulatory enforcement. Clay regularly provides strategic consulting on complex quality and regulatory matters including quality system development, remediation, regulatory submissions and clinical studies. In addition to his duties at Shriner & Associates, Clay currently provides strategic direction as a board member to a number of life sciences companies across the globe.

brendan oleary headshot square

brendan oleary headshot square

Brendan O’Leary, Digital Health Technology Consultant

Brendan O’Leary provides consulting services on digital health and medical device regulatory strategy to technology developers, healthcare organizations, trade and professional associations, and other stakeholders.

Brendan worked at the FDA for 14 years in a variety of roles, most recently as the founding Deputy Director of the Digital Health Center of Excellence and as its Acting Director throughout 2022. Brendan contributed to hundreds of precedent-setting decisions and co-authored dozens of policy documents that continue to provide the foundation for the FDA’s digital health efforts. He frequently represented the FDA on digital health and other topics through presentations at conferences and professional society meetings, press interviews, and interactions with Congress. Brendan also made significant contributions to the federal government’s response to SARS-CoV-2.

Bernhard Kappe Photo

Bernhard Kappe Photo

Bernhard Kappe, CEO and Founder, Orthogonal

Bernhard Kappe is the Founder and CEO of Orthogonal. For over a decade, Bernhard has provided thought leadership and innovation in the fields of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems. As a leader in the MedTech industry, Bernhard has a passion for launching successful medical device software that makes a difference for providers and patients, as well as helping companies deliver more from their innovation pipelines. He’s the author of the eBook Agile in an FDA Regulated Environment and a co-author of the AAMI Consensus Report on cloud computing for medical devices. Bernhard was the founder of the Chicago Product Management Association (ChiPMA) and the Chicago Lean Startup Challenge. He earned a Bachelor’s and Masters in Mathematics from the University of Pennsylvania, and a Bachelor’s of Science and Economics from the Wharton School of Business.

Randy Horton

Randy Horton

Randy Horton, Chief Solutions Officer, Orthogonal

Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech.

Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).