About Us
Regulatory Strategies, Inc. was founded in early 1993 with the goal of providing regulatory, clinical and quality services to medical device companies.
Regulatory Strategies has extensive experience in global regulatory for Class I, II, and III medical devices including the following areas:
Cardiovascular Neurology Respiratory
Urology Orthopaedic Ophthalmology
Gastroenterology Drug Infusion Otorhinolaryngology Wound Healing Combination Products Interventional Radiology
Services include:
Creative global regulatory and clinical strategies
Initial OUS clinical studies
Interface and negotiate with FDA and international regulatory agencies
510(k), IDE, PMA and HDE applications
Technical Files and Design Dossiers
Product labeling and advertisement programs review
Quality systems compliant with FDA QSR and ISO 13485
Complaints and MDR/Vigilance systems
Recall and field actions
Quality system auditing and training programs