Med-Di-Dia
Categories
Representative Body
- Unit 5A, Galway Technology Centre Mervue Business Park Mervue Galway H91 D932
- +353 (0)91-704804
- Visit Website
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 Device, 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
Regulatory Strategy for US, EU and Rest of World
Assessments against new EU Medical Device / IVD regulations (2017) to assist with transition to new requirements
Device classification & predicate device searches (US)
US FDA Regulatory Submissions
Clinical evaluations
Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)
Technical file compilation
Rep/Contact Info
Mr. Jay Shah
- Phone: 0868513732
