Med-Di-Dia

Representative Body

Hours:

Mon 9a.m.–6p.m.
Tue 9a.m.–6p.m.
Wed 9a.m.–6p.m.
Thu 9a.m.–6p.m.
Fri 9a.m.–6p.m.

Sat - Sun Closed

Driving Directions:

https://goo.gl/maps/mGncdQP9jyZ2RNa96

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