Regulatory

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Developing a Robust Global Regulatory Strategy

Layer 6 - Essential Principles specializes in crafting comprehensive global regulatory strategies tailored to the unique demands of the medical device industry. Our team of seasoned experts is dedicated to guiding your product through every regulatory hurdle, ensuring seamless market access and compliance. 

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Regulations and requirements often vary by country, level of risk, indications for use, and intended use. Our regulatory experts can help you better navigate the process and gain a clearer understanding of the regulations that apply.

We work with you to design and implement a regulatory strategy, prepare and submit the required marketing applications, and serve as your liaison from start to end, helping you to negotiate with FDA and international regulatory agencies efficiently and effectively.

Submission Development and Management

We work with your team to review, prepare and submit the required deliverables, with the goal of effectively addressing potential regulatory concerns and minimizing additional questions. The L6EP regulatory professionals have an extensive history of preparing and submitting successful regulatory submissions across the globe, including the following:

  • Pre-submission support documents (including US Q-submissions)
  • 510(k) Premarket Notifications
  • Investigational Device Exemption Applications (IDEs) and Clinical Trial Authorizations (CTAs)
  • Premarket Approval Applications (PMAs), Supplements, Annual Reports, and Postmarket Reports
  • 513(g) Requests for Classification
  • Technical Documentation for CE Marking
  • Canadian License Applications
  • International Marketing Submissions