Sequence Group

SEQUENCE GROUP › ABOUT COMPANY

Expert Medical Device Consultants

ABOUT US

Who We Are

Sequence Group is a leading medical device consulting firm, providing expert guidance and support for all aspects of medical device development and regulatory affairs. Our team of consultants is made up of experts in regulatory compliance, product design, software development, and quality management, who bring a wealth of experience and expertise to every project.

At Sequence Group, we believe that a positive and supportive work environment is critical to success. That's why we are committed to fostering an atmosphere of collaboration, creativity, and teamwork, where everyone is encouraged to contribute their ideas and expertise.

Our expertise and experience, combined with our positive work environment, set us apart from other consulting firms. We are always looking for new and innovative ways to help our clients succeed, and we are dedicated to delivering exceptional service and results on every project.

Regulatory Affairs
510(k), PMA, EU MDR, worldwide submissions
Quality Management
ISO 13485, FDA QSR, audits & inspections
Software (SaMD)
IEC 62304, cybersecurity, software V&V
Product Development
Design controls, DHF, risk management
LEADERSHIP

Meet the President

Nick Soro
Nick Soro
President, Sequence Group LLC

Nick Soro

Medical Device Executive · President of Sequence Group

A proven leader with a wealth of regulatory, technical, and operational experience, Nick Soro has spent over 20 years at the intersection of medical device engineering, regulatory affairs, and executive leadership. Most recently he served as Chief Operating Officer of Sensus Healthcare, a public medical device company that saw 6 consecutive quarters of record revenue and growth under his leadership.

Nick has an excellent track record bringing new device designs to market from concept through regulatory approval, overseeing manufacturing, regulatory, and development operations with a focus on improvements that streamline business development, promote continuous improvement, and maximize competitive advantage.

He founded Sequence Group in 2023 to bring that same executive-level expertise directly to medical device companies navigating the complex regulatory and development landscape.

20+
Years Experience
$45M+
Annual Revenue Led
25+
Countries Registered

Regulatory Expertise

ISO 13485 Quality Management
IEC 62304 Software Lifecycle
IEC 60601 Medical Electrical Equipment
ISO 14971 Risk Management
21 CFR Part 820 FDA QSR
21 CFR Part 807 510(k) Submissions
EU MDR 2017/745
ISO 10993 Biocompatibility
OUR EXPERTISE

Why Choose Sequence Group?

Medical Device Regulatory Affairs

  • New Product Development
  • US Regulatory Submissions
  • EU MDR Implementation
  • Worldwide Regulatory Strategies

Quality Management Systems

  • Audits and Inspections
  • Quality System Regulations
  • Acquisition Integration

Post-Market Surveillance

  • Post-Market Clinical Follow-up
  • PMCF Survey Development & Execution
  • Periodic Safety Update Reports
  • Quality System Integration
WHY WE EXIST
“Most of our clients come to us after working with another consultant or not getting the results they need. We provide expert guidance and knowledge that you can depend on.”
Work With Us

We provide expert guidance and knowledge that you can depend on.