Skip to content

Med-Di-Dia

Med-Di-Dia

Categories

Representative Body

About Us

Med-Di-Dia is a regulatory and quality compliance consultancy firm supporting Medical Devices, In-Vitro Diagnostics and Digital Health companies from our base in Galway, Ireland. We offer a range of services to fit your requirements including:
EU Authorised Representative
European Union Person Responsible for Regulatory Compliance - PRRC
Regulatory Strategy for US, EU and Rest of World
Assessments against new EU Medical Device / IVD regulations (2017) to assist with the transition to new requirements
Device classification & predicate device searches (US)
US FDA Regulatory Submissions
Expertise in defining medical devices and establishing their risk classification
In-depth understanding of borderline devices and the unique regulatory challenges they present
Clinical evaluations
Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)
Technical file compilation

Images

Managing Director Bobby Deal with then Mayor of Galway Cllr.Mike Cubbard
Director Greer Deal at Company Launch
Glimpses from the Launch Day
Team Members and Colleagues
Our Team
Welcoming application of New Regulations
Innovation Workshop for Medical Device Manufacturers

Rep/Contact Info

Ms. Tara Fahy
Regulatory Affairs/Quality Consultant
Ms. Marie Gallagher
Regulatory Affairs/Quality Consultant
Card image cap
Mr. Jay Shah