Bridging Consulting LLC

BRIDGING CONSULTING LLC is a Southern California-based boutique Regulatory, Quality and Clinical consulting firm dedicated to providing strategic and operational consulting services to AI startups and medical device companies. We strictly follow all timelines and focus relentlessly on quality and results. Our approach is to cultivate long-term partnerships with our clients.

 

Consulting Services Provided

REGULATORY:

  • Medical device status determination
  • Device classification
  • Indications for use and target claims
  • Regulatory pathway determination
  • Predicate device and competitor device research
  • Special control proposal¬†
  • Breakthrough and STeP device designation
  • FDA Q-sub meeting request and preparation
  • Pre-market submission (510(k), De Novo, PMA, HDE)
  • FDA deficiency response
  • Advisory committee panel meeting preparation
  • U.S. agent and FDA communcations
  • Labeling, ad/promo, and social media compliance
  • EU medical device regulation (EU MDR)

QUALITY:

  • Quality strategy
  • Quality system setup and assessment
  • Risk management
  • 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:

  • Clinical requirements determination
  • FDA negotiation on pre- and post-market clinical strategies
  • Study protocol development
  • Significant risk (SR), non-significant risk (NSR) and exempt study determination
  • Biostatistics, data management and data programming
  • IDE application
  • Clinical operation support
  • Clinical evaluation report (CER) preparation
  • Bioresearch monitoring (BIMO) inspection preparation

 

Examples of Products Represented (in Last 12 Months)

  • Machine learning MR image recognition software for lumbar spine disease detection
  • Deep learning intraoperative surgical assistance software for arthroscopic surgeries
  • Deep learning ultrasound guidance app for deep vein thrombosis detection
  • Wearable EEG system and deep learning algorithm for epilepsy detection
  • Machine learning smartphone app for health monitoring, pre-diagnosis and telehealth
  • Artificial stent graft for total or partial aortic arch replacement
  • Remote patient monitoring for personalized telemedicine
  • Diabetes management solutions
  • Blood pressure and vitals monitoring system
  • Wearable patch pump for heart failure management
  • Wearable electrical muscle stimulation system for sports performance enhancement
  • ECG-based remote monitoring system
  • Implantable ventricular assist device for heart failure treatment
  • Home-use virtual reality (VR) system for neurodegenerative disorder diagnosis
  • Nutrition and energy management system
  • AI-based setting optimization software for deep brain stimulation (DBS) therapy
  • Machine learning skin lesion analyzer for melanoma detection

 

Website

www.Bridging-Consulting.com

 

E-Mail

info@bridging-consulting.comm

 

Phone

(818) 519-0661

 

Please visit www.Bridging-Consulting.com or contact us to schedule a FREE consultation meeting.