Med-Di-Dia, a regulatory affairs and quality compliance consultancy focusing on the Medical, Digital Health and Diagnostic sectors of the European Life Science Industry, officially opened their Galway Offices on Monday 16th September 2019. The Mayor of Galway, Cllr Mike Cubbard was there to officiate the launch event at the Galway Technology Centre.
This new venture has been established in Galway to become an integral part of the highly innovative MedTech community. By providing regulatory input early in the development process, the Med-Di-Dia team will determine the most beneficial regulatory pathway to market. The team will also ensure that a company gathers good quality data at the right time along the development journey towards commercialisation, saving time and money. By getting the regulatory strategy determined from the outset, companies will have a smoother and faster route to their target market.
A key challenge for established MedTech companies is achieving compliance with the new EU Medical Device and In-Vitro Diagnostic Regulations. Med-Di-Dia aims to work closely with in-house teams to plan and implement transition to full compliance as painlessly as possible.
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.
There are some key differences between the new regulations and the previous EU Medical Device Directives. These new regulations go beyond design, development and manufacturing requirements by regulating the full and ongoing lifecycle of a product requiring information to be continually updated.
The company has ambitious plans to grow to at least 30 jobs over 3 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 Greer “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. As a company, we’ve decided to be proactive about this and engage with the Universities to offer internships to offer an insight into regulatory affairs and provide on the job training. All our employees, no matter how experienced or in-experienced, will receive ongoing training for their own personal development and to provide the best support to our clients. We will promote regulatory affairs as a 'cool' career and help to develop the next generation of regulatory professionals,” explained Med-Di-Dia Director Greer Deal.
“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.”
We get a buzz from seeing a product on the market which we've helped to get there. The thrill of knowing that we've guided that company through the maze of regulations, liaised and negotiated with the authorities and finally, there it is and available to everyone. Above all, we know that we've helped to ensure the product is safe, of good quality and that it works. This is one of the best feelings in the world.
“Our mission is to place regulatory affairs at the heart of every medical technology company and be the 'go to' consultancy for all your regulatory requirements. With passion and drive we have the flexibility to provide a cost-effective, bespoke solution which exactly fits the needs of you, the client.
“We are passionate about all things regulatory especially in the complex environment of Medical and Digital technology. We will cut through the maze of regulations and be a risk partner on the journey to the market never forgetting that, at journey's end, patients will be the beneficiaries. “
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. With a dedicated team, Med-Di-Dia will be the launchpad into Europe.
“If you want to go global, no problem! Med-Di-Dia has the full support of Global Regulatory Services' worldwide network of consultants who provide in-country knowledge as well as regulatory expertise”, said Greer.
For more information check out https://med-di-dia.com/. Med-Di-Dia Limited is located at Galway Technology Centre, Mervue Business Park, Galway.
Importers and distributors are currently subject to fragmented national law obligations and responsibilities. Replacing the current council directives 93/42/EEC, 90/385/EEC, 98/79/EC, as amended with the European Regulation (EU ) 2017/745 and 746 will require that all economic operators in the medical device and in vitro diagnostic chain be subject to the same rules throughout Europe.
These rules originate from the EU’s New Legislative Framework for the Marketing of Products (also known as the Goods Package ), consisting of Regulation No. 765/2008 on Market Surveillance and Decision No. 768/2008 on the Marketing of Products. This regulation outlines a common framework of general principles which reference provisions for the creation of community legislation harmonizing the conditions of product marketing.