To help you with the maze of regulatory requirements, RBC maintains capabilities to assess and meet a broad range of U.S. and international regulations related to designing, developing, manufacturing, launching and servicing regulated product.

Our regulatory approach begins with an up-front analysis of your product’s target markets.  Once the applicable certifying bodies and regulations are identified, a thorough assessment is performed to determine which parts of the regulations apply to your product. 

This is a key milestone as cost/benefit determinations are made concerning strict regulatory adherence versus rationale – points that can significantly affect your product’s cost and development schedule.

Once the regulatory approach is planned, each specific requirement is identified and integrated into the Product Requirements Document or into a separate Regulatory Requirements Document, depending on your preference*.  The product is then designed to meet these detailed specifications.  The loop is closed through full verification, validation and certification of your product to the regulatory requirements. 

Some of the key certifications commonly obtained in the course of an RBC project are:

• FDA (PMA, 510(k), Rationale)
• FCC
• UL (UL, CUL, CULUS)
• CSA
• CE Mark (Numerous Notified Bodies)
• Proprietary Marks (TUV, BEI)
• Individual Country Certifications (Asia, Latin America, etc.)