51ÁÔÆæ

When you’re seeking new product approval internationally, you need the guidance of experts that have worked with regulatory authorities around the world. 51ÁÔÆæ will work with you to create successful global regulatory strategy through services such as:

• International Regulatory Strategies
• Product Classifications
• FDA 513(g) Request
• International Registration

Before you even submit your product for approval to the top regulatory authorities, you’ll need to have a strategy in place to determine the most appropriate pathway to obtain clearance. You’ll be far more prepared to talk to the FDA and other regulatory bodies as we support you with services including:

• Preparing and Conducting Pre-Submission Meeting with FDA
• Regulatory Strategy
• Evaluation of ISO 13485 and FDA Compliance

Whether you’re only submitting your product for approval in your own country or are looking to sell in markets around the world, 51ÁÔÆæ will create a strategy unique to your goals. We help you navigate the 510(k) approval process for medical devices and guide you as you work with regulatory authorities from around the world. Our domestic and international services include:

• Technical Writing: 510(k) submissions, PMA submissions, De Novo, Technical Files, Clinical Reviews, Explanation Letters, etc.
• Submission Preparation and Filing with Regulatory Authorities
  • Pre-Market Notification (510(k))
  • Pre-Market Approval (PMA)
  • Innovative Regulator Pathways (i.e., De Novo)
  • Humanitarian Use Device (HUD) and Device Exemption (HDE)
  • European Union Technical Files and Class III Design Dossiers
• Facilitation and interaction with regulatory authorities