We Can Help You Get There Easier, Faster and for Less

  • FDA 510(k) paperwork preparation and submission
  • Establishment of quality system protocols and documents
  • Guidance on testing protocols and coordination/negotiation with laboratories
  • Revision engineering 
  • Labeling and packaging assistance
  • Establishment of distribution channels

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The USA medical device market is more than $100 Billion.

source: US Dept. of Commerce

For medical technology companies seeking an efficient and effective path to U.S. regulatory approval, BB Medical Surgical offers a variety of services to get you there. We understand exactly what it takes to commercialize a medical product in the U.S. market, keeping up-to-date on regulatory changes that impact our clients.

BB Medical Surgical offers a clear, concise yet fully comprehensive approach, ensuring your company meets FDA 510(k) submission requirements with the right testing, costs and paperwork.

  • We have saved clients up to $40k on FDA 510(k) applications
  • Fee-friendly for smaller MedTechs
  • Custom services because there is no “one size fits all” approach
  • Broad range of expertise
  • Collaborative team of professionals with specific expertise and experience matched specifically to the client