Regulatory: MedTech

Submission Management

Full-service submission support

The Alira Health team will work closely with you to prepare, review, and submit regulatory documents to address regulatory concerns and minimize delays.

Our team has an in-depth understanding of the extensive testing and documentation associated with the following medical device regulatory requirements:
  • Pre-submission preparation and submissions
  • Lead and manage pre-submission FDA meetings
  • 510(K) premarket notifications
  • DeNovo 510(k) premarket notifications
  • Investigational device exemption applications (IDES)
  • Premarket Approval Applications (PMAs)
  • 513(G) requests for classification
  • Requests for designation
  • Technical files/design dossiers for CE Mark
  • Canadian license applications

Why choose Alira Health?

With Alira Health as your partner, you will benefit from:

  • Innovation support, optimizing product development success every step of the way
  • Integrated and collaborative teams experience
  • Lifecycle approach

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