FDA Clearance or Approval

At Bioana, regulatory starts right in our very first engagement with you by understanding the intended use and technology of your medical device. Our regulatory team conducts a regulatory assessment to determine device classification, predicate devices, primary mode of action, regulatory pathway applicable testing, and other product specific and general establishment requirements. 

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Once regulatory strategy is set, our team will make sure to deliver as output of our design and development process a complete documentation package for regulatory submissions and transfer into commercial production. (Design History Files, Device Master Records, Pilot Production Device History Records, Technical File, etc.) 

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Our team of experts and regulatory partners can also support your regulatory application process, either with pre-submissions or your actual submission. We can also work with you or your regulatory consultants to help with full regulatory clearance. 

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A strong regulatory strategy leads to success, let’s clearly demonstrate that your device is safe, effective and compliant to accelerate market entry! Call us to meet with one of our experts. 

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Get the perfect strategy for fast clearance to market for U.S. and Mexico.

• Regulatory Strategy Development
• Tailored Quality System Design (FDA GMP)
• Quality System Procedures
• Quality Management and Assurance
• Establishment Registration and Device Listing
• Design Controls 21 CFR 820.30
• Design History File Documentation
• Device Master Record Documentation
• 510(k) Application
• UDI Requirements Compliance FDA-COFEPRIS Homologation