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

MedTech
News July 22, 2021
Alira Health Welcomes Fredrik Nyberg as Partner and Regional Head
We are pleased to announce that Fredrik Nyberg has joined Alira Health as Partner and Regional Head
Regulatory
Events July 20, 2021
Webinar Recap: Risk Management & Regulatory Submissions
Download Alira Health's Senior Vice President, Regulatory Affairs, Mary McNamara-Cullinane's webinar presentation, How to Implement Risk Management into Regulatory Submissions Using(...)
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Publications July 20, 2021
Infographic: The Pre-IND to Market Approval Roadmap in the U.S.
Download our latest infographic, The Pre-IND to Market Approval Roadmap in the U.S.
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Events July 15, 2021
Event: Cardio Wearables 2021 Conference
Join Piergiulio Lauriano for an exclusive discussion on Cardio Wearables Investments and M&A Trends during the conference.
MedTech Pharma
Events June 30, 2021
Event: Bio Asia-Taiwan
Join Daniela Sica, Vice President, Business Development, Pharma & Biotech, and Shu-Ling Cheng, Partner, at Biotechnology Innovation Organization's Bio-Asia Taiwan July 21-25, 2021.
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Publications June 2, 2021
Infographic: U.S. Go-to- Market Strategy Design for Wearable Technology in Healthcare
When our client, a European healthcare-based startup developing wrist wearables wanted to expand to the U.S., the Alira Health team helped develop a go-to-market strategy for this new segment.
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Publications May 14, 2021
Pocket Guide To MedTech’s Market Outlook In 2021
In this article Carlo unveils findings and summaries from The 2021 MedTech Contract Manufacturing Report, recently published by Alira Health in collaboration with Life Science Intelligence(...)

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