The program has a duration of 12 weeks, and upon its successful completion, a Certificate of Specialization is awarded, accompanied by 8 ECVET credits.
Through this program, you will learn:
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What the international trends in biomedical technology are
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How clinical investigations of medical devices are conducted
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How the medical device market is organized and monitored
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What the regulatory framework for medical devices is (MDR, certification, compliance, CE marking, etc.)
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How the technical and clinical documentation of a medical device is submitted and evaluated
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What the requirements of the ISO 9001 and ISO 13485 quality management standards for medical devices are
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How internal quality audits for medical devices are conducted
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What the quality and safety management procedures in biomedical technology are
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What the basic principles of health economics are
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What is provided by legislation regarding the protection of personal data (GDPR)
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What the procedures are for vigilance, reimbursement, and market placement of medical devices
More information about the training program, registration, participation cost, and course start dates is available at: https://biotech.cce.uoa.gr |
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