|
European Directives require that manufacturers based outside of the
EU appoint a representative based in the EU.
Horizon Phoenix, with offices located in Ireland, provides cost effective
representation services for medical device, biotechnology and personal
protective equipment manufacturers.
Horizon Phoenix will not only fulfil your representation obligations
but also:
-
Liaise and coordinate negotiations on your behalf with the 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 labelling, manufacturers
instructions for use and/or other technical documentation.
-
Archive documentation as required by European Directives, Competent
Authorities 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 European regulatory
environment to keep you apprised of new or revised requirements
and options which may be available for compliance.
-
Both European and North American 24 hour Customer Service at
602-200-4981. Experts available to you 24 hours a day.
Ask Us How!...
Why Horizon Phoenix?
-
Absolute confidentiality - we are not importers nor distributors;
your product related information is in safe hands.
-
Each Horizon Phoenix partner is fully accredited within their field
of expertise, e.g., Medical Device Consultant; Medical Device Lead
Auditor, etc. Some even hold academic appointments at major Universities.
|
