Roberta Hines is the founding President and CEO of the Northwest Clinical Research Group (NCRG). Roberta has 30 years of senior level experience as a successful regulatory professional in the medical device industry. She brings a unique blend of expertise in regulatory affairs, quality assurance and clinical research in Class I, II and III devices including wide variety of surgical and percutaneous cardiovascular implants, implantable orthopedic devices, neurovascular implants, interventional cardiology and endovascular devices, combination drug/device products, diagnostic cardiovascular devices, ventilators, peripheral staple and atherectomy devices, various ancillary accessories and medical equipment including software and hardware driven devices. Additionally, Roberta is an expert in the design and development of Quality Management Systems and has implemented these systems for many companies.
With experience in strategic regulatory and clinical research planning, we guide companies in bringing their products from concept through global market introduction in the fastest time possible. The experienced staff at NCRG is steeped with expertise in clinical trial design and management, quality system maintenance and regulatory submissions. Our contracted suppliers are highly experienced in First in Man, CE Mark studies, and US IDE studies specializing in cardiovascular, endovascular, neurovascular, and orthopedic devices.
NCRG has a full set of SOPs and related forms/tools for regulatory, quality systems and clinical work. Roberta Hines, principal at NCRG, has long-term relationships with several FDA branch chiefs, reviewers and Notified Bodies.
Call us at (626) 796-3376, email us at info@innoventz.com , or use the Request Information form.