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EU Market Access | US Regulatory Submissions
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:
We have the resource, the scientific and technical know-how as well as the regulatory expertise to help fast-track your devices and IVDs to the healthcare services and the patients who are most in need.
Don't let regulatory hurdles slow down your progress,
Cut through the chase and let our experts help you navigate the regulatory maze!
Feel Free to contact the team at:
Email: mdd@mddltd.com or Call: +353 (0)91 704804
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- 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
- Compliance and submissions related to REGULATION (EU) 2023/607
- 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
CORE SERVICES
EU AR / PRRC Services
We will be your EU AR or PRRC under the new EU Medical Device and In-Vitro Diagnostic Regulations.
EU Market Access
We can help you successfully CE Mark your device under the Medical Device Regulation and In-Vitro Diagnostic Regulation.
FDA Regulatory Submission
We can be your guide for clearance/ approval of your device in the US under the 510k, PMA and De Novo routes.
Email: mdd@mddltd.com or Call: +353 (0)91 704804
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 under the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) including EU Authorised Representative, for companies placing their products on the European market from small start-ups to multinationals. We also support companies entering the US market in conjunction with our parent company, Global Regulatory Services (GRS). For companies looking to enter Rest of World markets, we can offer regulatory and compliance services to fit your requirements.
Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).
