The medical device product lifecycle is one that rarely takes a linear path. As a clinical need for a product is captured many challenges are faced to develop and manufacture a safe and effective product. Added to this complexity is the legal requirement to develop, manufacture and market this device in compliance with a country's regulatory framework. Developing and implementing a regulatory plan for a product requires both the technical understanding of the device and its application in its therapeutic environment, an advanced understanding of the regulatory requirements and the ability to interact with the FDA and Competent Authorities to achieve a client's ultimate goal, achieving and maintaining market clearance in the most efficient and effective manner.
RQMIS understands how the product lifecycle must be integrated with these regulatory requirements. Our experience in the area of Quality Systems reflects our understanding in how product realization/design controls capture the device's design and verifies/validates the design safety and effectiveness, how design transfer can establish a robust manufacturing process and how CAPA and Risk Management can provide effective feedback processes that maintains/improves the Quality System.
Utilizing the evidence produced during these processes RQMIS has successfully designed and executed clinical studies, written premarket submissions and passed both QSR and ISO/EN13485 audits by FDA and Notified Bodies, respectively. We can support your clinical trials, from feasibility and first-in-man through your pilot, pivotal and post market studies globally.RQMIS has been developing and implementing focused regulatory plans for class II (IIa and IIb) and class III medical device and combination products for over 14 years. RQMIS management has a combined experience of over 30 years in small to large companies and Clinical Research Organizations and at the FDA (in both ODE and in the Field).