Orthogonal Appoints Megan Graham as Vice President of Regulatory and Quality

Chicago, IL — Orthogonal is pleased to announce the appointment of Megan Graham as its new Vice President of Regulatory and Quality. This pivotal role was created to expand Orthogonal’s capabilities in quality management and regulatory affairs, ensuring that MedTech clients receive expert guidance in navigating the evolving healthcare software and clinical AI/ML landscape.

A Proven Leader in Digital Health

Megan brings over 25 years of experience as a software engineer and quality/regulatory professional, having worked for leading organizations such as 美敦力 and Mayo Clinic and multiple MedTech startups. In 2015, she launched her digital health consulting practice to help founders and business leaders develop and commercialize innovative healthcare technologies amid an ever-changing regulatory environment. Her expertise spans:

• Healthcare AI/ML
• New product development
• Safety and risk management
• Security, privacy, and compliance strategies

Throughout her career, Ms. Graham has collaborated with organizations in the U.S. and internationally, guiding them through diverse medical device classifications, remote monitoring technologies, AI/ML governance, and emerging industry standards. Notably, she has served on management teams that achieved approvals for Independent Diagnostic Testing Facilities (IDTF), enabling the launch of paid clinical services through CMS.

Driving Orthogonal’s Regulatory & Quality Strategy

In her new role, Ms. Graham will expand Orthogonal’s Regulatory and Quality services to help MedTech firms more effectively bring Software as a Medical Device (SaMD) and other digital health solutions to market. By leveraging her broad expertise, Orthogonal aims to support clients across all stages of product development and regulatory compliance, ensuring that patient outcomes remain at the forefront of every project.

Executive Endorsement

“We are excited to welcome Megan to Orthogonal,” said Bernhard Kappe CEO of Orthogonal. “Her deep industry knowledge, passion for innovation, and proven track record in guiding disruptive technologies through complex regulatory pathways will be instrumental in accelerating our clients’ success. We look forward to the new opportunities her leadership will create for Orthogonal and the MedTech partners we serve.”

About Megan Graham

A passionate advocate for connecting patients, physicians, and healthcare professionals with innovative solutions that improve health, Ms. Graham is an adjunct professor at the 美国明尼苏达大学双城分校 , a guest lecturer and speaker, an advisor, and a published author. She holds degrees in Mathematics and Software Engineering from the University of Minnesota, alongside certifications from ASQ and ISO. As an active Regulatory Affairs Professionals Society (RAPS) , HIMSS , and AAMI member, Ms. Graham remains at the forefront of advancements and best practices in the digital health industry.

About Orthogonal

Orthogonal is a software development consulting firm that believes in improving patient outcomes faster. We do this by helping MedTech firms build and evolve their Software as a Medical Device (SaMD) and digital ecosystems faster.

For More Information

For more details about Megan Graham’s appointment and Orthogonal’s services, please visit orthogonal.io or reach out to our media contact:

Media Contact: Ben Trombold, MBA , VP, Sales & Marketing, [email protected]