Curso Q-76 Técnico en Productos Sanitarios

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- Identify the regulatory framework for marketing medical devices and in vitro diagnostic medical devices in Europe and Spain
-Understand the rules for classifying in vitro medical and diagnostic products, as well as medical software
- Train to prepare the technical documentation that proves the conformity of medical devices in different stages
- Learn the requirements of a quality management system as per ISO 13485 for manufacturers of medical devices

1. Classification of medical devices:
1.1. Medical devices
1.2 Medical devices for in vitro diagnosis
1.3 Software as a medical device
1.4 In-house medical devices
2. Legal requirements for the CE mark in Europe and Spain:
2.1. Regulations (EU) 2017/745 and 2017/746
2.2 Current Royal Decrees in Spain
3. Unique identification (UID) and EUDAMED database:
3.1 Unique identification system (UID)
3.2 Reporting requirements through the EUDAMED database
4. The risk management associated with medical devices (MD/IVD) as per ISO 14971:
5. The ISO 13485 standard for managing the quality of medical devices
6. Technical documentation:
6.1. Technical documentation for obtaining the CE mark for medical devices
6.2 Documentation for post-marketing follow-up
7. Clinical evaluation and research:
7.1 Managing the clinical evaluation process of medical devices.
7.2 Clinical research on medical devices for humans as per ISO 14155 on good clinical practices
8. Promotional labelling and material:
8.1 Legislation regulating the advertising of medical devices intended for the public
8.2 Differences between advertising aimed at the public and that aimed at healthcare professionals
9. Technical documentation for obtaining the CE mark for medical devices for in vitro diagnosis
10. Implementation of a follow-up system as per Regulations (EU) 2017/745 and (EU) 2017/746