Trust the Medical Device Regulatory Experts

Whether struggling with a submission strategy and execution or dealing with regulatory compliance, we stand ready to support your medical device regulatory services needs. Our consultants have years of experience as regulatory and compliance leaders and can help establish solutions for any challenges that surface.

Our services highlighted in the handout include:

• US FDA Traditional Regulatory Strategy and Submissions, such as PMA and 510(k)
• Innovative Regulatory Pathways such as De Novo Requests
• Humanitarian Use Device (HUD) and Device Exemption (HDE)
• FDA Pre-Submission Meeting preparation and support
• European Union Technical Files and Class III Design Dossiers
• Clinical Evaluation Reports
• Global regulatory strategy and product classification
• Global registration submissions

To begin the Regulatory Compliance Associates^® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.