Biotech Research Group has certified regulatory affairs professionals that have years of experience working with the FDA throughout the pharmaceutical, biologics, and medical device industries. Why hire one FDA 510k consultant when you can have a group of savvy FDA 510k consultants that will carefully consider all strategies and alternatives during each step of the regulatory process? Biotech Research Group has expertise with a wide range of medical devices across all classes. Medical devices are increasingly more challenging from a regulatory perspective. Biotech Research Group is here to help you navigate through FDA’s ever-changing world of regulations. We will take care of all matters concerning the regulation and compliance of your medical device or combination product. Our FDA 510k consultants will prepare your 510k submission, plan testing, manage communications with the FDA and any other items that will be needed through the approval process or post-marketing requirements. Partnering our medical device consulting expertise with your internal 510k developers is a smart choice, allowing your medical devices to get to market faster without costly delays. Years of experience mixed with strategic approaches, allow you to maintain project control while accessing the specialized medical device expertise you need 24/7.

Some of our services include :

  • Pre-market requirements
  • Post-market requirements
  • 510k submission
  • De Novo submission
  • IDE submission
  • Pre-market approvals (PMA)
  • Medical device classification
  • Medical device registration & listing
  • Medical device recalls
  • Importing/exporting medical devices
  • Combination products
  • FDA communications
  • 513(g) Request for Information
  • HUD/ HDE submission

BRG has the experience required to obtain 510k FDA clearance. The BRG team has helped our clients achieve their goals. BRG’s offers extensive 510k services including:

  • Evaluate the classification of your medical device
  • Determine the proper FDA product code and regulation number
  • Gap analysis of your medical device documentation
  • Select the proper predicate for your medical device
  • Review testing requirements for your medical device
  • Provide you with a list of necessary documentation required
  • Collect the data and documentation needed and prepare the 21 sections of the 510k submission
  • Coordinate the payment of your FDA review fee on your behalf
  • Complete the 510k submission package and ship to FDA
  • Answer any and all follow-up question for the FDA reviewer
  • Prompt responses to your questions and we keep you updated during the review

Click here to contact us about your project.