EudaMed.eu and Ambit BST announce a strategic partnership to train the medical device sector on EUDAMED
EudaMed.eu, the leading company in EUDAMED training and EUDAMED software and Ambit BST today announced a strategic licensing and training partnership. Ambit BST will offer EUDAMED training as EudaMed.eu’s exclusive partner in Spain.
This partnership supports the medical devices industry as it responds to increasing EU regulatory and compliance demands arising under the new MDR and/or IVDR regulations mandated by the EU.
The MDR regulations as they are known, come into effect in May 2021 and will impact medical device manufacturers and distributors worldwide, as they race to meet the new import and internal compliance requirements, effective across the EU, by year-end.
The EudaMed.eu Ambit BST alliance takes place at a time of radical regulatory change for the medical device industry. EUDAMED is a significant EU innovation and provides Europe with a comprehensive system for traceability, clinical evaluation, and subsequent market surveillance for medical devices, and indeed, the companies that operate in the sector.
This partnership brings together critical and timely knowledge to help client companies ensure regulatory compliance, and improve efficiency and competitiveness for clients, in their continuous mandatory interactions with EUDAMED.
“Helping medical devices companies gain regulatory compliance through consulting and services requires continuous adaptation and an in-depth understanding of the regulations, combined with other skills, confidence, rigour, and comprehensive customer training. The alliance with the greatest expert in EUDAMED is a clear example of our aim on offering excellent services that ensure preparation for regulatory compliance of companies and facilitate the daily operations of our clients. ,” says Josep Hortigüela, Medical Devices Officer of Ambit BST.
“MDR EUDAMED is a very complex system requiring a lot of research and understanding by medical device companies. We have found our training sessions save companies several weeks of research, just to get started, and it gives them a deep understanding of MDR EUDAMED. This alliance with Ambit-BST is very exciting for Eudamed. We will now be able to share our knowledge with the Spanish speaking companies helping them navigate the complexities of MDR EUDAMED. There was a lot of interest from Spanish companies in our training and software, and we feel very lucky to have signed this agreement with AMBIT-BST. I believe this alliance will hugely benefit the Spanish MedTech industry.” says Richard Houlihan, CEO of EudaMed.eu
EudaMed.eu was formed to help the MedTech industry with the complexities arising from the European Commission’s EUDAMED system. Under the medical device regulations providing medical device data to EUDAMED is mandatory for MedTech companies wishing to sell their products in Europe. The EudaMed.eu CEO Richard Houlihan lead the European Commissions IT teams developing EUDAMED and using this insightful knowledge he is leading EudaMed.eu in building software solutions and exclusive EUDAMED training programs for the MedTech industry.
About Ambit BST
For more than 15 years, Ambit BST has served national and international companies with specialized solutions and services related to information technology (IT) and digital transformation.
In early 2020 Ambit BST, merged with CSV experts, consolidating its medical device and pharmaceutical business units, expanding specialized consulting services and offering a training program for the health care industry.