WHAT WE DO

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

WHY RCB

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

• 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

MORE ON OUR SERVICES

Our Clients

Our long term clients include Fortune 500 Companies, mid-sized 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