Med-Di-Dia Limited

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 which exactly fits the needs of you, the client.

Time critical services:

 Person Responsible
For micro and small companies, we will be your Person Responsible under the new EU Medical Device and In-Vitro Diagnostic Regulations.

 Authorised Representative
For non-EU and UK companies, we can be your Authorised Representative within Europe.

 Legal Representative for EU Clinical Trials
For UK organisations running EU-wide clinical trials, we will be happy to act as your Legal Representative to ensure continuity of your trials post-Brexit at a minimal cost.

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’s 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 & preventive action, product classification, notified bodies