In the clinical research of Medical Devices, as with medicines, the aim is to combine the guarantees of protection of the participating subjects and the guarantees of reliability of the data generated.
Therefore, the ethical and methodological principles of clinical trials with medicines and medical devices are the same, with the only limitations inherent to the nature of the research.
At Azierta, we are experts in Medical Devices: we prepare the documentation and manage the application for clinical trials
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We offer the services of the best professionals in medical devices consultancy
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Our services in medical devices:
- Market Access
- CE marking
- Marketing licences
- Company registry
- Certificate of Free Sale
- Quality Systems
- Implementation of quality systems
- MDSAP
- Marketing
- Support for marketing