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

Contact us

BB Medical Surgical medical device commercialization. FDA 510(k), QSR, MDR, Regulatory & Auditing Services

source: US Dept. of Commerce

For medical technology companies seeking an efficient and effective path to U.S. regulatory approval, BB Medical Surgical offers medical device commercialization to get you there. We have extensive experience in guiding MedTech companies both in the U.S. and abroad through the FDA 510(k) approval process. 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 to U.S. medical device commercialization, 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.

While there are numerous regulatory consultant companies that specialize in filing 510(k) applications, their fees can be cost-prohibitive for smaller MedTechs. In our experience, many tend to take a “bigger is better” approach, recommending a “kitchen sink approach” that serves to increase costs and paperwork without offering added benefit to their customers. Furthermore, many regulatory consulting firms have a narrow scope of expertise that limits them from offering knowledgeable guidance outside of the filing process. 

Understanding that there is no “one size fits all” approach to regulatory approval, BB Medical Surgical works closely with clients to structure individualized programs. While many MedTech companies come to us initially for FDA 510(k) paperwork, they often tap into our broader range of expertise. When a client requires resources to meet its product commercialization needs, BB Medical Surgical builds a collaborative team of professionals with specific expertise and experience matched specifically to the client. Our collaborators include engineers, clinicians, regulatory affairs professionals and marketing experts. Leveraging these resources, BB Medical Surgical assists with key processes critical to successful commercialization, from engineering and packaging/labeling configurations to marketing and sales strategy.