Med-Di-Dia Limited
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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
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, quality management, person responsible for regulatory compliance, cyber security, internet of medical things, european union authorised representative, iomt, samd, artificial intelligence, machine learning
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