Aesthetica-tech regulatory consulting will develop and implement a competitive and cost effective regulatory strategy, prepare and submit marketing application, and serve as your liaison from start to finish, helping you prepare for and respond to regulatory agency questions. For both professional and consumer devices.
Our Services Include:
*FDA regulatory document preparation & submission 510(k)
*Establishment registration and Device Listing
*Certificate of Foreign Government
*Assistance with Medical Devices saftey testing, evaluation, and certification, to standards such as IEC 60601-1,