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Representative Body

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

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Mr. Jay Shah
  • Phone: 0868513732