Services Regulatory Affairs NCRG provides expertise in worldwide regulatory strategies and brings knowledge and understanding of US and international regulations to our clients. Our regulatory affairs team has over 50 years of experience combined. We can help you develop the best strategies with accelerated results in the approval process. Completing your goals with excellence and timeliness requires understanding of the regulatory requirements. Our staff's experience is a key element to your success. Quality Systems NCRG has over 25 years of experience & expertise in the design, development and implementation of quality systems & quality assurance principles in compliance with the U.S. Quality System Regulation & ISO 13485. We facilitate the ISO Certification & CE Marking process from selection of the Notified Body to managing and maintaining quality records, Design History Files and implimenting internal audit programs. Clinical Research NCRG provides clinical support from study design and site selection to study closure and everything in between. Our vast clinical knowledge and globally experienced clinical research associates provide essential support throughout the clinical trial. Through project management tools we can assure you that your timelines and objectives are being met. Contract Services Capitalizing on regional expertise and minimizing travel costs, NCRG employs several contracted personnel around the world to monitor studies, provide data management, and to conduct statistical analyses. Our contracted suppliers are highly experienced in First in Man, CE Mark and US IDE studies specializing in cardiovascular, neurovascular, pulmonary and orthopedic devices.		Testimonials "Roberta and the NCRG team guided our company and technology through a very difficult regulatory assessment path with the FDA. Initially, the FDA determined our device was definitely on a very lengthy and costly PMA pathway which would have been detrimental to the success of our venture. NCRG was responsible for helping us develop a successful strategy which resulted in the FDA reversing their initial decision and recommending our device for a 510(k) filing. Their established relationships with key members of the FDA enabled us to also a build a strong relationship with the agency to support our project. The NCRG team was also instrumental in helping us build a robust quality system and successful design transfer to manufacturing. On the O.U.S. side the NCRG advised, created, and helped us execute a successful 60 patient, multi-centre trial for CE Mark. To sum up our experience, we found Roberta and her team to be friendly, knowledgeable in all aspects of Regulatory Affairs, clinical trial design, quality assurance, and they delivered these services “on time” and “on budget”. I strongly recommend them to any medical device start-up." - James L. Greene, CEO, MitralSolutions, Inc.  "Roberta and her team at NCRG have been a pleasure to work with - professional and personable. NCRG are definitely experts at what they do and have consistently exceeded my expectations on quality of work and timeliness of meeting deliverables. They have excellent relationships with centers/physicians they conduct early clinical trials with and have dramatically increased the probability that our new medical technology will ultimately be commercialized. I highly recommend working with Roberta and the others at NCRG.” - Trevor McCaw, CEO, Aegis Medical Innovations, Inc. "I have known Roberta for over 30 years. As CEO of SVTI, I hired Roberta and her consulting company to help with regulatory strategy including FIM strategy. I found Roberta to have continued her high degree of integrity, detailed knowledge of regulations and creativeness that she demonstrated 30 years ago. It is refreshing to see her prosper while maintaining her high degree of ethics and integrity. Roberta has assembled an outstanding group of regulatory and clinical professionals to support her clients. Roberta goes to the extreme to be assured that her clients are supported and receive the strategic information to position a company for the best success for clinical and regulatory approvals. I highly recommend Roberta and her professional staff for any regulatory or clinical objectives." - Todd Campbell, Former CEO, Specialized Vascular Technologies, Inc.  "“Roberta has orchestrated regulatory strategy of my company on day one. She has developed a comprehensive, insightful, and visionary regulatory assessment of our device. Additoinally, Roberta has recommended very professional reimbursement specialists. Roberta is professional, on-time, experienced, and resourceful. It is always a pleasure to meet and work with Roberta. And I wholeheartedly recommend Nothwest Clinical Research.” - Dr. Ali Hassan "Roberta has a wide range of experience in medical device applications and operates on a very practical, pragmatic and proactive approach well suited to start-up and/or innovative companies. She is an asset to any new product development team.” - Robin Stephens, Owner, Psephos Biomedica “Roberta is a pleasure to work with in developing worldwide regulatory and clinical strategies. Her experiences and knowledge are valuable assets contributing to successful programs for medical device development. I welcome the opportunity to work with Roberta and her team again in the future.” - Carol Ann Yarbrough, Director of Clinical Affairs, Pulmonx Roberta has a wealth of experience that is invaluable and would be an enormous asset to any company or colleague as a collaborator or advisor." - Laura Minarsch, President, MMC Medical