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 set up scalable and robust quality management systems (QMSs) that are compliant with ISO 13485, FDA Quality System Regulations (QSR) and EU Medical Device Regulations (MDR).
We strictly follows all timelines and focus relentlessly on quality and results. Our approach is to cultivate long-term partnerships with our clients.
YOU NEED ASSISTANCE
We frequently hear these and other questions from our clients. Recent years have witnessed the rapid adoption of artificial intelligence (AI)—including machine learning (ML) technologies—as well as explosive growth in mobile medical apps, digital health and wellness products and a continual drive toward “closing the loop” in therapies by combining sensing and therapy delivery technologies.
More than ever, startups, medium-sized or even well-established medical device companies need help navigating their way through U.S. FDA regulations, EU Medical Device Regulations (EU MDR) and other international regulatory requirements.
WE CAN HELP
With deep regulatory, quality and clinical expertise—through collaboration with our alliance partners—BRIDGING CONSULTING LLC is ready to assist you by:
BRIDGING knowledge or resource gaps, to help you navigate your way through the increasingly complex and ever-changing global regulatory environment.
Understanding and BRIDGING regulatory requirement gaps, to introduce your overseas commercial device to the U.S. market through a 510(k), De Novo or PMA pathway.
BRIDGING geographic gaps as your U.S. agent and trusted in-country partner for all FDA-related communications.
BRIDGING relationship and knowledge gaps dealing with your FDA review division on meeting the latest agency expectations with regard to cybersecurity, risk management, human factors engineering and real-world evidence.
BRIDGING compliance gaps by responding to time-sensitive 483s and warning letters or making critical recall decisions.
Getting timely regulatory clearance or approval by BRIDGING pre-market and post-market clinical evaluation requirements.