Why use Horizon Phoenix experts . . .

Horizon Phoenix experts provide leadership and experience

• 400+ years’ experience in the research and development, design, manufacturing and use of medical devices, biotechnologies, IVDs and pharmaceutical products
• Quick turnaround time; we can meet very tight deadlines
• Multidisciplinary approach, your review team will consist of a regulatory expert, a physician/surgeon and other subject matter experts
• Well justified, peer reviewed data inclusion and exclusion
• Comprehensive examination of clinical data, published literature, complaints, field corrections, recalls, warning letters and other pertinent information
• Discussion not only on your device but on the performance of similar or related devices,
• An assessment of the state of the art in the practice of medicine in your target market
• Completely unbiased assessment that will be only regulatory compliant but also provide value adding insight on potential product enhancements
• Useful feedback for the entire product lifecycle – design, risk analysis, instructions for use, opportunities for improvement
• Insight on infrequently occurring risks and forecasts of potential long term issues
• Methodical process and written protocols
• Fully collaborative process – we work with your people so that knowledge and expertise reside in your company

What is to be gained…

• Clear and unambiguous regulatory compliance
• Early detection and resolution of defects or other shortcomings
• Valuable insight on potential design or performance improvements
• Keen insight on opportunities for next generation devices
• Improved marketing literature
• Cultivate unshakeable customer loyalty
• Opportunity for scientific articles in a peer reviewed professional journal that promote your device