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Medical devices | Regulatory consulting services

Uniquely positioned to offer both medical device development (through our sister company Sagentia Innovation) and in-house FDA regulatory expertise, TSG helps clients deliver FDA-compliant, innovative medical devices across the patient care continuum.

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Do you have a project you'd like to discuss with our team?

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We aim to understand our clients’ goals and objectives, learn the scientific and technical aspects of projects, and anticipate regulatory challenges to plan a strategic path forward.

Whether your company is in the initial stages of designing and developing a new medical device or completing the premarket submission, TSG can be your trusted partner in guiding you through the FDA regulatory process.

Medical specialities

Experienced in providing regulatory advice to companies ranging from small start-ups to multinational corporations, our expertise covers a broad spectrum of medical devices within the following specialties:

  • Anesthesiology
  • Cardiovascular
  • Dental
  • Ear, Nose, and Throat (ENT)
  • Gastroenterology and urology
  • General and plastic surgery
  • General hospital and personal use
  • In vitro diagnostics
  • Obstetrics and gynecology
  • Ophthalmology
  • Orthopedic
  • Neurology
  • Physical medicine
  • Radiology

USA FDA medical device regulation

We can help with device decisions, regulatory path determinations, performance data requirements, clinical study approval & reporting, premarket submissions, support with FDA meetings, and postmarket compliance.

Medical device development

Our sister company, Sagentia Innovation, helps both start-ups and large medical device manufacturers, design and develop ground-breaking devices and technologies. The leader of TSG’s FDA device regulatory practice also serves as the in-house FDA regulatory advisor to Sagentia Innovation’s medical device product development and advisory teams.

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