CYduct Diagnostics Inc (CYDX)

[Verticalmojo]

Why choose Emergo Group as your European Authorized Representative?

*We are one of the largest Authorized Representatives for medical devices and IVDs, representing hundreds of medical device companies worldwide.
*We are a well-established business founded in 1997.
Our familiarity with the European regulatory environment and Competent Authorities allows us to promote the best interests of our clients.
*We are an ISO registered firm which includes European Authorized Representation in the scope of our registration.
You will receive free updates on European regulations for medical devices.
*You will have secure online access to all of your documentation including Technical Files, Labeling Information and Symbols, Language Requirements, Directives, Guidelines, and more.
*We maintain offices throughout Europe, Asia, Australia, North and South America so we can serve you efficiently regardless of your time zone.



What is the role of an EU Authorized Representative?

*Registers your devices with the national Competent Authorities before they are marketed, where applicable.
Acts as your primary contact point for all national Competent Authorities.
*Maintains a current copy of your Technical File available for inspection by the European Competent Authorities.
*Gives you authorization to place our name and address on your device labels, packaging and Instructions for Use.
*Always available to interact between you and the national Competent Authorities.
*Responsible for Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities, in cooperation with you and your distributors.
*Protects the confidentiality of your documentation. The European Authorized Representative can only show technical documentation to Competent Authorities as required by law.
*Represents you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s).
*Maintains reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.
*Notifies or is notified by the Competent Authorities of serious device incidents or FSCA.


- See more at: http://www.emergogroup.com/services/europe/european-authorized-representative#sthash.Or6JC33g.dpuf