← REGULATORY AFFAIRS & QUALITY MANAGEMENT
Authorized Representative
Medical Device and IVD manufacturers must nominate a representative before commercializing their products in certain countries. Veranex’s global team of experts ensure that your products are compliant and can represent your interests, enabling your success in these target markets.
EU / Swiss Authorized Representative
Acting as an authorized representative for a manufacturer based outside the EU and/or Switzerland, requires a sound legal, regulatory and technical due diligence, which is in the best interest of the manufacturer and the EC-REP/CH-REP.
Veranex knows the specific requirements and responsibilities of both parties, and we establish authorized representative mandates that safeguard your company and your products.
By partnering with Veranex, you can be assured that your risk management process will be optimized to improve the safety and performance of your device, ultimately benefiting patients and users.
US Agent
The United States (US) Food and Drug Administration (FDA) requires that all non-US based medical device and IVD companies appoint a registered US FDA Agent, who must be a resident or maintain a physical place of business in the US.
As a US Agent, we serve as a liaison between your company and the FDA. With our established offices in the US, we can act as your US Agent and guide you through the specific US registration requirements.
How does it feel to work with the Veranex Authorized Representative Service Team?
In preparation for the market entry of your device, we review the applicable regulatory and general safety performance requirements and clarify insurance obligations, connecting you with leading liability insurance companies in the life-science field, if necessary.
Veranex also supports you making the necessary updates to your packaging, labeling and Instructions for Use (IFU) to comply with national requirements, including the local contact details of your authorized representative. Your device is then registered with the national Competent Authorities before being placed on the market.
After this, we continue to support by maintaining a current copy of your Technical Documentation, available for inspection by the European Competent Authorities; performing audits of your subcontractors located within the EU/CH (suppliers, distributors, etc.); and notifying the authorities of any major incidents pertaining to your products, when necessary.
Authorized Representative Services & Capabilities:
- Review and ensure product compliance
- Clarify insurance requirements, establishing contact with leading liability insurance companies in the life-science field
- European/Swiss contact details for your device labels, packaging, and instructions for use
- Device registration with the national authorities
- Perform audits of your subcontractors located in the EU/Switzerland
- Coordination of any possible incident resolution or field safety corrective action with the Competent Authorities