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

Related news

Blog November 22, 2023
Technological Innovations in Diabetes Management Medical Devices
Discover the notable trends in the diabetes management devices market including glucose monitoring, insulin delivery and digital health.
Diabetes MedTech
Blog November 17, 2023
Misconceptions About Patient-Centric Co-Design
Many people have misconceptions about patient-centric co-design, and these misconceptions are holding companies back.
Co-Design Digital Health MedTech Patient Centricity Pharma
Multimedia October 24, 2023
Clinical Trials & Hospital Pilots
Kenny Carberry, VP, Business Development, Research & Clinical Development, joins the “Clinical Trials & Hospital Pilots” webinar as speaker.
Clinical Trials MedTech
Publications October 17, 2023
Trends and Challenges in Diabetes Management Devices
Our experts had a look at the Diabetes Management Devices Market and identified the current regulatory and market access trends and challenges in this PM360 article.
Diabetes Medical Devices MedTech
Blog October 16, 2023
How to Co-Design a Solution with Patients to Meet Their Needs
To learn how you can benefit from a co-design approach and how to get started, we spoke with two experts on patient engagement and co-design.
Digital Health MedTech Patient Centricity Patient Engagement Pharma
Blog October 16, 2023
Macro Market Trends Impacting Cardiology Medical Devices
This article describes four key macro trends as outlined in our report, Cardiology Medical Devices Market Trends 2023.
Cardiology Medical Devices MedTech
Events October 15, 2023
Virtual Startup Demo Day
Join us and hear pitches from the leading startups in New England and beyond at the MassMedic Startup Virtual Demo Day.
MedTech Startups
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.