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Regulatory Affairs and strategic Planning for the Medical DEvice Industry





Regulatory Affairs for Medical Device Manufacturers

  • Strategic Planning

  • Global Regulatory Submissions and Communications

  • Labeling and Promotional Review

  • Post-Market Surveillance

  • Recall Coordination

  • Training & Oversight of Regulatory Affairs Departments



Working with us allows your company to leverage our knowledge without having to:

  • train or involve your current employees

  • add to your own regulatory department

We offer three levels of engagement:

  1. identify the deficiency and outline necessary correction

  2. identify the issue(s); outline the correction; and provide new templates, protocols, and staff training

  3. identify the issue(s); outline correction(s); provide templates, protocols, and staff training; and be there for continuous support to ensure that the corrections are permanent and staffing is efficient. This option often results in a net savings because of the staffing efficiencies that RCB allows in-house.

RCB ensures the regulatory process is efficient & strategic

We work directly with regulators on your behalf, allowing you to receive information without direct engagement


Our Clients

Our long term clients include Fortune 500 Companies, mid-sized device manufacturers, and start-ups—they have a few things in common.
Our clients:

  • Fully utilize RCB's efficiency when staffing resources are unavailable 
  • Take advantage of the Regulatory Strategy provided by RCB to save time, money, and effort
  • Utilize the procedures that RCB develops to maintain regulatory compliance
  • Ensure open communication so that RCB can be proactive in planning for their regulatory needs