Med-Di-Dia
@med-di-dia.com
Explore comprehensive medical device consulting services at Med-Di-Dia, specializing in regulatory compliance, CE marking, and market access, Med-Di-Dia offers expert guidance on MDR 2017/745, IVDR 2017/746, FDA submissions, and more to ensure your medical device's success, Navigate the complexities of medical device regulations with Med-Di-Dia’s tailored consulting services for global market access and compliance, Get specialized support for ISO 13485, ISO 9001, and post-market surveillance with Med-Di-Dia’s experienced regulatory consultants, Med-Di-Dia provides end-to-end solutions for medical device labeling, risk management, and technical documentation preparation, Ensure your medical device meets all regulatory requirements with Med-Di-Dia's consulting services for the EU MDR and IVDR transitions, Optimize your medical device compliance strategy with Med-Di-Dia’s expertise in quality management systems and regulatory submissions, Med-Di-Dia: Your trusted partner in navigating FDA and EU regulations for seamless medical device market entry and compliance, Discover Med-Di-Dia’s consulting services for cybersecurity in medical devices, ensuring protection against modern threats, Streamline your path to regulatory approval with Med-Di-Dia’s comprehensive consulting services for medical device conformity assessments, Med-Di-Dia supports medical device manufacturers with vigilance and incident reporting, UDI compliance, and PMCF requirements, Achieve regulatory excellence with Med-Di-Dia's consulting expertise in harmonized standards, authorized representative services, and more, Med-Di-Dia: Providing in-depth regulatory affairs consulting to help you succeed in the global medical device market, Ensure your medical device’s compliance with Med-Di-Dia’s consulting services for field safety corrective actions and recalls management, Med-Di-Dia offers strategic guidance on quality assurance, regulatory compliance, and market access for medical devices worldwide
Med-Di-Dia's Company Logos
Med-Di-Dia's Brand Colors
Hex Code
Color name
RGB
HSL
CMYK
#006999
Bahama Blue
0, 105, 153
199, 100, 30
100, 31, 0, 40
#FFFFFF
White
255, 255, 255
0, 0, 100
0, 0, 0, 0
#011C4B
Green Vogue
1, 28, 75
218, 97, 15
99, 63, 0, 71
About Med-Di-Dia
Med-Di-Dia is a regulatory and quality compliance consultancy firm based in Galway, Ireland, specializing in supporting Medical Device, In-Vitro Diagnostics, and Digital Health companies. We are passionate about helping innovative companies navigate the complex world of regulatory affairs and quality compliance. Our services include EU Authorised Representative, EU market access, and FDA regulatory submission, as well as compliance and submissions related to the latest EU Medical Device and In-Vitro Diagnostic regulations.
We offer expert guidance on device classification, predicate device searches, and clinical evaluations, in addition to assistance with mandatory standards such as ISO 13485:2016. Whether you are a small start-up or a multinational corporation, our team has the scientific, technical, and regulatory expertise to fast-track your products to the market. Don't let regulatory hurdles slow you down; contact our experienced team for a free consultation and let us help you navigate the regulatory maze
Company type
Privately Held
Year founded
2019
Company size
2-10 employees
