About
Methodical. Experienced. Diligent.
Supporting your needs from initial concept through commercialization, and the post-market phase.
Susan Noriega, founder and owner of RACC, has over 30 years of Regulatory, Clinical, Quality and Compliance experience working with over 100 small venture funded start-ups to large multinational corporations. In addition to her consulting experience, she has held executive leadership positions in regulatory, clinical, and quality at a number of small to large medical device and in vitro diagnostic companies.
The RACC Team specializes in the comprehensive development of effective global regulatory strategies, US, EU and other international submissions, clinical study design and management, and quality system development and assessments for the medical device and in vitro diagnostic industries. RACC has secured Class II and Class III regulatory clearances and approvals in the US, EU, Latin America, Asia Pacific, and other international regions. RACC has established excellent communications and relationships with US FDA, Notified Bodies, US and international CROs, as well as an established network of Legal, Regulatory, Clinical and Quality professionals.
Regulatory
RACC has over 30 years of experience working with over 100 medical device and in-vitro diagnostic companies in the U.S. and internationally, from small start-up companies to large multi-national corporations. RACC’s product experience is extensive, touching almost every clinical application and medical practice. Our expertise in developing comprehensive global strategies, preparing submissions, and securing regulatory clearances and approvals will foster the achievement of your company’s goals
Clinical
RACC develops and executes comprehensive clinical strategies to support US or OUS FIH, Pilot and Pivotal clinical studies in support of market submissions. Our experience with FDA, Notified Bodies, as well as Ethics Committees / IRBs and Competent Authorities facilitates an efficient path to successful clinical investigations.
Quality & Compliance
RACC develops and implements Quality Systems for small venture funded start-ups to mid-size companies in compliance with FDA Quality System Regulations and ISO 13485 Quality Standards. We partner with your team to develop a Quality System that is appropriate for the stage of product development and the size of the organization. The RACC team supports quality functions throughout the product development lifecycle, from concept through commercialization, as well as post-market activities.