+353 (0)91-704804

Medical Devices Digital Health Diagnostics I Don't Know Cosmetics Fractional Regulatory Consultant

EU Authorised Representative Person Responsible for Regulatory Compliance Cosmetics - Responsible Person Clinical Trials - Legal Rep EU Responsible Person Under GPSR

MENU menu

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).

GET IN TOUCH FOR MORE INFORMATION

+353 (0)91-704804

LATEST INSIGHTS

European Medical Device Nomenclature (EMDN): A Key to EU Compliance

European Medical Device Nomenclature (EMDN): A Key to EU Compliance

This comprehensive system is crucial for manufacturers who are navigating the complexities of EU regulations and EUDAMED

28.1.2025

The Human Touch in Regulatory and Quality Compliance: Why Consultants Still Matter in the AI Era

The Human Touch in Regulatory and Quality Compliance: Why Consultants Still Matter in the AI Era

Why not rely solely on AI for creating technical documents, implementing ISO standards, or managing regulatory and quality compliance?

23.1.2025

Mastering TPLC for Medical Softwares

Mastering TPLC for Medical Softwares

The Total Product Life Cycle (TPLC) encompasses all phases of a medical device's life, from initial concept through post-market surveillance.

14.1.2025