New Medical Device or Invitro Diagnostics
We first review and make an assessment to exclude that the product does not predicate or a possible reference product available legally in the market.…
Predicate Medical Device or Invitro Diagnostics
We make extensive national databases and regulatory requirements to ensure we can follow the least burdensome path for marketing the product. We assist with appropriate…
Premarket Notification of Medical Devices. Uncertainties in the Regulators Letter
You could start selling or exporting a product but wait! Within the regulator's letter, there may be clauses that require critical assessment and managing the…
Medical Technologies. Anticipation of the Current-Future Regulatory Framework and Credible Data
Medical technologies have increasingly raised the hope of quick, inexpensive, user-friendly platforms with the possibility of improving the way healthcare is managed. Medical technologies are…
Medical Device
Assessment, Guidance, and Compilation for Premarket Approval of Medical Device
We review the data presented, provide guidance for the need for any further development, and help in the compilation of the data generated by your…
