Sequence Group · Consulting
Regulatory & quality services
End-to-end regulatory and quality support for medical-device companies, from quality systems and FDA submissions to audits, international market access, and US Agent representation. Backed by 20+ years bringing FDA-cleared products to market.
What we do
Services
Quality Management Systems
ISO 13485 QMS build, implementation, and remediation, from startup to scale.
ISO 13485
Gap assessments, implementation, and certification readiness.
FDA 510(k)
Submission strategy, authoring, and clearance, start to finish.
European MDR
CE marking and technical documentation under EU MDR 2017/745.
MDSAP
Medical Device Single Audit Program readiness across markets.
Auditing
Internal audits, supplier audits, and mock FDA / notified-body audits.
Product Development
Design controls and Design History Files from concept through launch.
US Agent Services
FDA US Agent representation for non-US manufacturers.
FAQ
Frequently asked questions
Who is Nick Soro? +
Nick Soro is a medical-device executive with 20+ years bringing FDA-regulated products to market. He is the founder of Sequence Group, a medical-device regulatory and quality consultancy in Fort Lauderdale, FL, and former Chief Operating Officer of Sensus Healthcare (NASDAQ: SRTS).
What does Sequence Group do? +
Sequence Group provides end-to-end regulatory and quality services for medical-device companies: FDA 510(k) submissions, ISO 13485 quality management systems, EU MDR and MDSAP, auditing, design controls and product development, and FDA US Agent representation.
Can you author and submit an FDA 510(k)? +
Yes. Nick Soro has authored and submitted 510(k) submissions to the FDA, including the GentleBeam clearance (K250692). Services cover 510(k) strategy, authoring, and clearance from start to finish.
Which quality and regulatory standards do you support? +
ISO 13485, FDA 21 CFR Part 820, IEC 62304 (software lifecycle), ISO 14971 (risk management), EU MDR 2017/745, MDSAP, and FDA pre- and post-market cybersecurity guidance.
Do you provide FDA US Agent services? +
Yes. Sequence Group provides FDA US Agent representation for non-US medical-device manufacturers.
Do you offer fractional or interim executive leadership? +
Yes. Nick Soro offers fractional and interim leadership (including COO-level operations, regulatory, and quality) for medical-device and health-technology companies.
Where are you located and who do you serve? +
Sequence Group is based in Fort Lauderdale, Florida, and serves medical-device and health-technology clients across the United States, the European Union, and worldwide.