Alira Health

Alira Health

Medical Device Regulation Compliance

Navigate the complex details of Medical Device Regulation (MDR) with our experts

The MDR changes the legal framework for medical devices in Europe.

All new medical devices entering the European market must be compliant to the new MDR requirements. For those already in the market, a transition period has been established, during which manufacturers must recertify their medical devices in accordance with the new regulation.

As your regulatory partner, we can help you navigate the complex MDR environment for the successful certification of your medical device in the European market.

We already support manufacturers asking questions like:

  • How will the MDR’s new requirements impact my existing devices?
  • Will I be able to benefit from what is outlined in the MDR transition timelines extension?
  • What are the steps I need to take to be compliant with the MDR?
  • How can I leverage the data that I have already generated for my device?

Our MDR solutions are backed by expertise

As regulatory consultants, we help our clients in the management of both transition and first submission to the MDR. We identify and prioritize requirements and build a strategy to implement the scientific specifications.
Ainoa Forteza presenting

Thanks to our cross-functional team spread between the US and EU, and an extensive network of consultants and KOLs, we ensure tailored strategies, efficient interactions, and successful submissions.

Why Partner With Us on MDR?

Medical Device Regulation:
A Checklist for Preparation

This checklist can provide you with insight into where you stand in regards to MDR preparation and what you still need to address.

Regardless of where you stand today, Alira Health is here to help you manage the transition to the MDR

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