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Marie Gallagher at Medical Technology Conference


On 21st October, 2021 our Regulatory Affairs/Quality Consultant, Marie Gallagher presented an overview of the importance of a regulatory strategy in the MDR/IVDR world. This session was one of the key ‘must listen to’ topics especially because IVD regulations are right around the corner. Many companies are facing a tough time to transition their innovation and comply with IVDR.


Marie Gallagher at Medical Technology Ireland

Marie started with giving a brief introduction to Regulatory Strategy helping the audience to understand why a regulatory strategy was an important step whilst innovating a medical product.


A regulatory strategy:

Marie Gallagher Med-Di-Dia at Medical Technology Ireland

Additionally, a regulatory strategy can serve as the basis of the marketing + financial planning process. Our experts have helped 68 companies with a robust regulatory strategy and today, these innovations are successful products complying with MDR/IVDR requirements.


Innovators need to understand the aspects of a regulatory strategy and Marie clearly highlighted these during her presentation as she mentioned that a regulatory strategy:

As an innovator, the above points should emphasise to you the importance of a Regulatory Strategy and so, by now, you should have your mobile phone in hand and sending an email to to receive expert advice for your medical innovation.

Regulatory Strategy for Medical Devices EU AR

If not …

Here are some more facts highlighting the importance of a regulatory strategy:

Our experts have 25+ years of expertise in the MedTech sector. Feel free to send us an email to for one FREE consultation. This consultation can get your medical device compliance activities up and running.


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