hi,
I want to find a european representative for medical device.my company is a consultant company and our clients want to find european Authorized representative. Authorized Representative’s essential duties are listed in the Medical Device Directive
? Essential Duties required by Law:
? Authorization to place its name, address, phone number on our device labels etc.
? Acting as our primary contact point for the EU Authorities.
? Keeping our technical file documentation ready and available for the European Competent Authorities.
? Protecting our documentation confidentiality because they are authorized to show them to the Competent Authorities only.
? Notification of serious device incidents to the Competent Authorities
? Simplification of the Risk Analysis
? Co-signing of the Declaration of Conformity
? On-site visits
? Notification of changes and amendments to the Medical Device Directive that affect our device(s).
actually the most important thing you should do is to supply your address and name so that to facilitate our clients to contact with EU competent authorities.
is that all clear??
so anyone interested in supplying this service? please feel free to contact me
ruby
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