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

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Developing Data Specialist Talent: Collaboration Is Key
Companies across Pharma and MedTech need talented people to cover the range of data-related challenges. Discover what this means for developing talent throughout the industry.
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Multimedia June 21, 2022
Increasing Access to Genomic Testing in Europe
Listen to the episode “Increasing Access to Genomic Testing in Europe: The role of national genomic initiatives in increasing uptake of Advanced Diagnostics”.
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The Impact of Chip Shortage on the MedTech Sector and RAS Players
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Events May 19, 2022
DIA 2022 Global Annual Meeting
We are pleased to announce that we will be joining DIA 2022 Global Annual Meeting as exhibitors and delegates.
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News May 11, 2022
Alira Health Acquires RedCrow, an Equity Crowdfunding Platform for Healthcare Startups
We acquired RedCrow, an alternative investment platform that provides individual investors with easy access to expert-vetted healthcare start-ups. The financial terms of the transaction(...)
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U.S. and European Regulatory Strategies for Asian MedTech Startups
This webinar will focus on the U.S. FDA and EU MDR/IVDR regulatory pathways and strategies for medical device startups based in the Asia Pacific.
MedTech Regulatory
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