Case Studies

Request:

Irish company with a borderline product needed help in approaching the Health Products Regulatory Agency (HPRA). Objective was to have their product confirmed as a Medical Device and to launch into Europe.

Outcome:

We compiled evidence to support the product as a medical device and sought confirmation from the HPRA. After discussion with the agency, we were successful in obtaining medical device classification for the product and are currently working on a strategy to rollout to the rest of Europe.

Request:

A non-European medical device manufacturer requested support to achieve compliance with EU regulations in order to market their custom-made devices in Europe.

Outcome:

We delivered a regulatory strategy report which was then used as the framework to work with for achieving compliance with the appropriate regulations. EU compliant Technical Files were completed and registration with the Irish Health Products Regulatory Agency (HPRA) was successful. Currently acting as EU Authorised Representative and Person Responsible for Regulatory Compliance to ensure ongoing compliance.

Request:

A spin-out company with a novel Class IIa medical device requested guidance on their approach to the global market.

Outcome:

We helped them to define their target markets and provided them with a regulatory strategy report which was validated by in-country regulatory specialists. This report has provided them with a roadmap for their target markets and currently, we are supporting them through their implementation phase (including registrations).

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LATEST INSIGHTS

EU AR and EU Market

EU AR and EU Market

Operating without an EU Entity?
You could be at risk of a Product recall, Penalty or legal action!

6.3.2023

ISO 13485 Importance

ISO 13485 Importance

When it comes to medical device manufacturing, patient safety depends on the quality and consistency of medical products.

2.3.2023

ISO 13485 Requirements

ISO 13485 Requirements

2.3.2023