Med-Di-Dia, a regulatory affairs and quality compliance consultancy focusing on the Medical, Digital Health and Diagnostic sectors of the European Life Science Industry.
With passion and drive, we have the flexibility to provide a cost-effective, bespoke solution that exactly fits the needs of you, the client.
Time-critical services:
- Person Responsible for Regulatory Compliance For micro and small companies, we will be your Person Responsible under the new EU Medical Device and In-Vitro Diagnostic Regulations. #PRRC
- European Union Authorised Representative For non-EU and UK companies, we can be your Authorised Representative within Europe. #EUAR / #EAR
- Legal Representative for EU Clinical Trials For organisations running EU-wide clinical trials, we will be happy to act as your Legal Representative to ensure continuity of your trials at a competitive price.
Ongoing and routine services:
- Help to define your product and develop your regulatory strategy.
- Expertise to ensure a successful EU CE Mark registration.
- Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)
Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS) www.globalregulatoryservices.com
Company Details
- Employees
- 12
- Founded
- -
- Address
- Galway Technology Centre, Mervue Business Park,ireland
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- med-di-dia.com
- Keywords
- Regulatory Affairs, Quality Compliance, Medical Devices, Digital Health, Diagnostics, EU Authorised Representative, EU Person Responsible, EU Legal Representative, Technical Files, Regulatory Strategy, Clinical Investigations, Clinical Evaluations, Design Files, Design Control, Software Validation, Risk Management, ISO 13485, Quality Management Systems, Corrective and Preventive Action (CAPA), Product Classification, Quality Management, Person Responsible for Regulatory Compliance, Cyber security, Internet of Medical Things, European Union Authorised Representative, IoMT, Internet of Medical Things, SaMD, Artificial Intelligence, Machine Learning, Cyber Security.
- HQ
- Galway, Galway
Med-Di-Dia Limited Questions
Med-Di-Dia Limited's website is med-di-dia.com
Med-Di-Dia Limited's LinkedIn profile is https://ie.linkedin.com/company/med-di-dia-ltd
Med-Di-Dia Limited has
12 employees.
View email and phone details for 12
employees at Med-Di-Dia Limited.
Med-Di-Dia Limited's industry is
Medical Equipment Manufacturing
Med-Di-Dia Limited's top competitors are
Td Medical Bv,
Med Dimensions,
Fleming Medical Ltd,
Med-Dyne, Inc.,
Synaxial,
Medatec,
Med-Electronics, Inc.,
Med Device Talent,
Global Regulatory Services Ltd,
Topra - The Organisation For Professionals In Regulatory Affairs.
Med-Di-Dia Limited's categories are Medical Equipment Manufacturing
Med-Di-Dia Limited's founding year is 2019
