US Agent/AER
USFDA requires companies based outside of the United States to appoint a US Agent to act on their behalf. European Directives require that manufacturers based outside of the EU appoint a representative based in the EU. Horizon Phoenix provides both of these services for less than you are probably paying for either one!
Horizon Phoenix will not only fulfil your regulation representation obligations but also:
- Liaise and coordinate negotiations on your behalf with the FDA or Competent Authority in cases of disputes with your notified body regarding quality system registration, product certification or testing, medical device risk classification, CE marking, product labeling, manufacturers instructions for use and/or other technical documentation.
- Archive documentation as required by USFDA, European Directives or national legislation.
- Register manufacturers of Class 1 products, custom made devices, systems or procedure packs and those involved with the sterilization of medical devices.
- Liaise with all European member states and relevant Competent Authorities for vigilance, post market surveillance and other product related issues.
- Give you a competitive edge by monitoring the regulatory environment to keep you apprised of new or revised requirements and options which may be available for compliance.