Obtained 510(k) Market Clearance for new Medical Device

Posted by Bob Duffy on April 5, 2017 in Regulatory & Standards Compliance Projects

Challenge

Customer needed Market Clearance for new Medical Device.

Actions

• Organized testing and documentation needed to submission.
• Led product Verification and Validation activities.
• Created and submitted 510(K) Premarket Notification for Electronic Medical Device.
• Interacted with FDA to respond to requests for additional information and resolve issues.
• Prepared and submitted responses to FDA requests for additional information.

Result

Customer received FDA clearance to market the new product.