Med-Di-Dia Limited

medical devices

About

Med-Di-Dia Limited is a consultancy based in Galway, Ireland, specializing in regulatory affairs and quality compliance for the Medical, Digital Health, and Diagnostic sectors within the European Life Science industry. Established in December 2018, the company provides expert regulatory guidance and compliance services to help clients navigate the complexities of EU regulations. The core services offered by Med-Di-Dia include acting as an EU Authorised Representative, serving as the EU Person Responsible for Regulatory Compliance, and providing support for EU MDR and IVDR Regulatory Compliance as well as US FDA Regulatory Compliance. The company emphasizes early regulatory input during product development to streamline market access and ensure product safety and quality. Med-Di-Dia targets medical device manufacturers, digital health companies, and diagnostic firms looking to enter the European market. The company is dedicated to supporting its clients through the challenges posed by new regulations and the impacts of Brexit. Headquartered at Platform94 in Galway, Med-Di-Dia is actively involved in the local MedTech community, contributing to its growth and innovation.

Technologies

Outlook Microsoft Office 365 Mobile Friendly AddThis Hubspot Google Analytics

Keywords

eu legal representative eu person responsible medical devices regulatory strategy design control diagnostics eu authorised representative artificial intelligence quality compliance notified bodies clinical investigations software validation iomt machine learning corrective & preventive action quality management systems design files product classification technical files internet of medical things samd digital health iso 13485 person responsible for regulatory compliance european union authorised representative cyber security clinical evaluations regulatory affairs euar risk management

Location

Wellpark Road, Galway, County Galway, Ireland

Related Companies

Companies in the same industry