Bridging Consulting Llc

Bridging Consulting LLC is a boutique Regulatory, Quality and Clinical consulting firm dedicated to providing strategic and operational consulting services to AI startups and medical device companies. We collaborate with our clients to map out optimal clinical and regulatory paths to help achieve speed-to-market while minimizing regulatory and compliance risks. We help our clients to set up scalable and robust quality management system (QMS) that are compliant to ISO 13485, FDA Quality System Regulations (QSR) and EU Medical Device Regulations (MDR). Bridging Consulting LLC always focuses on quality, timelines and results. We aim to cultivate lasting partnerships with our clients. REGULATORY services: • Medical device status determination • Device classification • Indications for use and target claims • Regulatory pathway determination • Predicate device and competitor device research • Special control proposal for 510(k) • Breakthrough and STeP device designation • FDA pre-submission ("Q-sub") meeting preparation • Pre-market submission (510(k), de novo, PMA, HDE) • FDA deficiency response • Advisory committee panel meeting preparation • U.S. agent and FDA communications • Labeling, ad/promo and social media compliance • EU medical device regulation (EU MDR) QUALITY services: • Quality strategy • Quality system setup and assessment • Risk assessment • Cybersecurity • Human factors engineering and usability evaluation • Data privacy • Corrective and Preventive Action (CAPA) support • Field Corrective Action (FCA) determination and preparation • Inspection preparation and support CLINICAL services: • Clinical requirements determination • FDA negotiation on pre-market and post-market clinical strategies • Study protocol development • Significant risk (SR), non-significant risk (NSR) and exempt study determination • IDE application • Clinical operation support • Clinical evaluation report (CER) • Bioresearch monitoring (BIMO) inspection preparation