Medtech consultancy firm Med-Di-Dia is going to be creating 30 jobs in Galway with the opening of its new offices in the city this week.
Med-Di-Dia works with medtech companies to help them get their products to the market by helping them comply with regulatory obligations in this sector.
The company officially opened their Galway offices on Monday with Mayor of Galway Mike Cubbard officiating, and announced plans to create 30 new jobs over the next three years.
We are acutely aware that there is a skill shortage in the life sciences and the shortage of regulatory expertise is even worse.” said co-founder Greer Deal.
“We need to train the next generation of regulatory specialists to try and ‘plug’ this skill shortage and have enough resource to support the increasing regulatory demands of the MedTech sector,” she added.
A key challenge for established MedTech companies is achieving compliance with the new EU Medical Device and In-Vitro Diagnostic Regulations.
Med-Di-Dia says that by ensuring regulatory compliance is baked in to the development process in medtech from the outset, and by making sure good quality data is gathered at the right time, they can ensure a smoother path to the market, saving both time and money.
The company owes its origins in part to Brexit and the New European Regulations, which are increasing the burden and complexity of regulatory compliance for Medical Device and Medical Diagnostic Companies operating in Europe.
There are some significant changes to the regulatory obligations of legal manufacturers, importers and distributors involved in the MedTech supply chain.
Greer said that to ensure they have access to skilled graduates in Galway to meet these challenges they are working with local universities to offer internship programmes.
“Galway is a hotbed of innovation especially for the MedTech sector. The Med-Di-Dia team is embracing every aspect of Galway life. We will be supporting start-ups, entrepreneurs and well established MedTech companies,” Greer said.
Med-Di-Dia was spun out of Global Regulatory Services to provide the key services of EU Authorised Representative, EU Person Responsible for Regulatory Compliance and EU Legal Representative for Clinical Trials.