Services

Regulatory Affairs Compliance Consultants provides Regulatory, Clinical and Quality support and expertise that are tailored to meet the needs of your organization. Whether your organization requires an on-site or a virtual / remote solution, we will partner with your team to provide results that support your company’s goals and objectives.  RACC provides an agile and efficient team that is very hands-on and solution oriented.  Our team’s breadth of expertise and years of experience, coupled with extensive relationships with US FDA, Notified Bodies, US and international CROs, as well as an established network of Legal, Regulatory, Clinical and Quality professionals, will help ensure your success.

Regulatory Affairs

  • Develop comprehensive and effective global regulatory strategies

  • Support Class I, Class II and Class III medical and in vitro diagnostic devices

  • Establish early collaboration with FDA via Presubmission process: informational meetings, design verification / validation test plans, pre-clinical and clinical strategies and study designs

  • Submit FDA Breakthrough Device Designation; received designation for multiple device technologies

  • Submit 510(k) Submissions; has received clearance for over 120 510(k)s

  • Submit IDE, HDE and PMA Submissions, original PMA, PMA Supplements, Real Time Reviews for Class III devices

  • Support device classification strategies; successful re-classification efforts

  • Develop comprehensive programs for CE Marking under MDD and MDR Transition. 

  • Support Notified Body Selection

  • Develop and submit Class Ir, Class IIa/ Class IIb and Class III Technical Documentation, including ERCs and GSPRs, for approval in support of CE Mark (MDD and MDR)

  • Support international submissions and registrations in Latin America, Asia Pacific (Australia, Japan, China, Taiwan) and other international regions

  • Perform labeling and promotional / advertising materials reviews and claims assessment

 

Clinical

  • Develop clinical strategies to support new devices and expanded indications: FIH, Pilot and Pivotal

  • Initiate early feasibility and FIH experience to facilitate clinical assessments

  • Develop / assist with clinical protocols / study designs

  • Develop essential documentation in support of clinical investigations

  • Secures IRB / EC and regulatory authority approvals

  • Clinical Evaluation Reports (CER)

  • Post Market Clinical Follow Up (PMCF)

Quality & Compliance

  • Develop and implement Quality Systems for small start-ups to mid-size organizations; lead 13485 Certification and Medical Device Regulation (MDR) transition planning and execution

  • Risk management activities

  • Complaint management and AE reporting (Medical Device Reporting and Vigilance)

  • Post-Market Surveillance (PMS) activities

  • Internal and external Quality System audits

  • Support Design Control activities, including Design Verification and Validation (DV&V) test strategies and planning

  • Quality Improvement Processes (QIP)

  • Management representative functions / management reviews