Med-Di-Dia Limited

A regulatory and quality compliance consultancy firm supporting Medical Device, In-Vitro Diagnostics and Digital Health companies from our base in Galway, Ireland. The company specialises in compliance with the EU Medical Device Regulation 2017/745, IVD Regulation 2017/746 and UK Medical Device Regulations 2002 providing a range of services including:

• EU Authorised Representative (EU-AR)
• Person Responsible for Regulatory Compliance (PRRC)
• Transitioning from the 'old' directives to the new EU Medical Device / IVD regulations (2017) 
• Device risk classification & conformity pathway to market
• Clinical Evaluation Reports (CERs)
• Risk Management
• Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)
• Technical file compilation in order to obtain CE Mark and/or UKCA Mark
• Regulatory Strategy for EU, UK, US and Rest of World 
• US FDA Regulatory Submissions including predicate device searches for 510(k) pathway