| 2. Request and maintenance of the certification of sanitary products. |
2.1. Application to a notified body.
2.2. Marketing and commissioning.
23. Process and regulations related to clinical investigations.
2.4. Surveillance and inspection system.
2.5. Quality system.
2.5.1. Application regulations.
2.5.2. Implementation.
2.5.3. Audits. |
| 4. Characteristics and requirements of invention patents, utility models and industrial designs. |
4.1. Patentability.
4.2. The invention patent.
4.3. The European invention patent.
4.3. The utility model.
4.4. Industrial design.
4.5. The distinctive signs.
4.6. Requirements to apply for a patent.
4.6.1. Novelty.
4.6.2. inventive activity
4.6.3. industrial application.
4.6.4. Executable
4.7. Patent right.
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| 6. Innovation in biomedical technology. |
6.1. Innovation and entrepreneurship in medical technologies.
6.2. Innovation tools: innovation management methods.
6.3. Technology transfer environments in biomedicine. |
Practices.
Certification and industrial protection of a biomedical product. R&D&i management in the health sector.
In these practical exercises, the students will have to document the process that allows, on the one hand, the complete and correct certification of a medical device and, on the other hand, its intellectual and industrial protection in the field of biomedical engineering. There will also be an exercise on the integral management of healthcare R&D&i. |
1. Choice of product.
2. Analysis of preliminary steps and previous conditions.
3. Documentation and review of the health certification process.
4. Comprehensive management of healthcare R&D&i.
5. Documentation and review of the intellectual and industrial protection process.
6. Submission and presentation of the process. |
