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Regulatory & Quality Solutions LLC provides full-service regulatory affairs and quality assurance expertise to medical device organizations. Our mission is to navigate the complex regulatory landscape and determine the most efficient paths to a safe and effective product, cleared for U.S. and international marketing. This is accomplished through results-driven, experienced team members providing you with on-site leadership and support in all areas of regulatory affairs and quality assurance.

Regulatory & Quality Solutions has provided services for a wide variety of medical products, including the following:
  • Radiology Contrast Injectors and Syringes
  • Critical Care Ventilators and Patient Interfaces
  • CPAP Devices and Patient Interfaces
  • Newborn Nursery and Neonatal Intensive Care Devices
  • Neonatal Jaundice Management
  • Patient Management Software
  • Vital Signs Monitoring Devices
  • Surgical Convenience Kits
  • Combination Products
  • Ex-vivo Support Systems
  • Invasive Heat Therapy Systems
  • Portable Ultrasound Units
  • In-vitro Molecular Diagnostics
  • Disposable Disinfecting Devices
  • Peritoneal Lavage
  • Class III Electromechanical Devices and Disposables
  • Non-Medical Life Science Products