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

Publications February 2, 2023
Outlook 2023: Firms Prepare For ‘World Where Health Care Has No Limits’
In the latest publication by Medtech Insights by Pharma Intelligence, executives at top device companies and other stakeholders share their expectations.
MedTech Pharma
News January 31, 2023
The Playbook for Patient Engagement in MedTech in the U.S. is Launched
The MedTech Patient Engagement Think Tank announced today the launch of the Playbook for Patient Engagement in MedTech in the U.S.
MedTech Patient Engagement
Publications January 31, 2023
A Playbook for Patient Engagement in MedTech in the U.S.
“A Playbook for Patient Engagement in MedTech in the U.S.” is a result of amalgamating ideas, research, findings, and forecasts from industry subject matter experts that together(...)
MedTech Patient Engagement
Publications January 19, 2023
Medical Device Regulation in 2023: A Window of Opportunity
We spoke with our team of regulatory experts about the recent news regarding the MDR and the opportunity it presents to device manufacturers in 2023.
Medical Devices MedTech Regulatory
Publications January 19, 2023
What’s Next for Diabetes: Patient Engagement, Personalization, and Usable Technology
Alira Health partnered with the ADA to support this conversation and explore the most important topics emerging from patients, physicians, specialists, and patient advocates including(...)
Clinical Trials Diabetes MedTech Patient Engagement
Publications January 17, 2023
Insights on the MedTech Industry
In 2023, the MedTech industry will seek to turn the challenges of disruption into opportunities for lasting transformation. Discover the three keys that a successful MedTech company(...)
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Events January 11, 2023
MD&M West 2023
Join our colleague Carlo Stimamiglio for his presentation “MedTech CDMO: Market and M&A Trends in 2023”, as he goes over key takeaways from our upcoming 2023 US MedTech CDMO Report.
CDMO MedTech
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