Health Research International has more than 10 years of experience supporting new medical products as they move through the FDA regulatory process. We have an excellent relationship with FDA personnel and maintain close contact with them for the duration of each project to ensure the most meticulous, cost effective and rapid outcome. Our FDA experience encompasses:

• 510(k) submissions
• IDE submissions
• PMA submissions
• Acting as Chief Regulatory Officer for new and/or small companies
• Maintaining Design History Files on new products
• Setting up and coordinating clinical trials, both in the U.S. and off-shore
• Submission of IRB documents and related materials
• Summarizing clinical trial outcomes for FDA submission

Please contact Suzanne Ratzloff at 216-521-3321 if you would like discuss our regulatory services.