More than ever before you need expert advice on navigating the European regulatory maze on such important items as:

• EN harmonized standard based quality management system
• STED - Technical files demonstrating compliance
• Essential Requirements Checklists
• Presumption of Conformance
• Multiple European Directive compliance
• Labelling and instructions for use including translation, symbols and contraindications and warnings
• Design Dossier Reviews
• Post Market Surveillance
• Vigilance
• Authorized European Representation
• Registration with Competent Authorities
• Selecting and working with notified bodies

Let Horizon Phoenix experts help you with tough European Market Access questions such as:

• Can I self declare my product line?
• Do I need an authorized representative?
• What directives apply?
• Do I need a design dossier review?
• What are Harmonized Standards and which ones apply to me?

European market access, the second most important regulatory approval after a USFDA 510k! Horizon Phoenix experts have helped more than 600 companies get thousands of products European approvals. Products such as in vitro diagnostic test kits, digital radiography equipment, sterile surgical gloves, artificial organs, drug/device combinations, long-term implantables and many others. Every risk class, every major configuration, disposable, reusable, sterile, non-sterile - Horizon Phoenix has the experience you need.

European regulatory authorities uniformly apply their regulations to all companies and to all risk categories of product. It makes no difference if you are a multi-national conglomerate with billions of dollars in revenue or a five-person niche company funding your operations through a second mortgage.

There are many directives, which apply to medical devices including Reduction of Hazardous Substances (RoHS), Waste from Electrical and Electronic Equipment (WEEE), Personal Protective Equipment (PPE), Electromagnetic Compatibility (EMC), Electromagnetic Immunity (EMI) and many others. Don’t get half way through your testing only to find out you are headed in the wrong direction!

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Why Horizon Phoenix?

Horizon Phoenix has helped more than 600 companies achieve CE Marking for everything from sterile surgical instruments to disposables to diagnostic imaging and implantable cardiovascular devices.

On time, under budget, we can do the same for you...