SubjectsSubjects(version: 895)
Course, academic year 2021/2022
  
Management and quality systems in production of biomaterials - M106013
Title: Systém managementu a jakosti ve výrobě biomateriálů
Guaranteed by: Department of Metals and Corrosion Engineering (106)
Actual: from 2020
Semester: winter
Points: winter s.:5
E-Credits: winter s.:5
Examination process: winter s.:
Hours per week, examination: winter s.:3/0 Ex [hours/week]
Capacity: unlimited / unknown (unknown)
Min. number of students: unlimited
Language: Czech
Teaching methods: full-time
Level:  
For type: Master's (post-Bachelor)
Note: course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: Volenec Karel doc. RNDr. PhMr. CSc.
Interchangeability : N106039
Annotation -
Last update: Pátková Vlasta (04.01.2018)
The aim of the subject is to give basic information on the management system and regulations connected with the production of medical devices and biomaterials. In addition, specific aspects of the production of medical devices and biomaterials will be given.
Aim of the course -
Last update: Pátková Vlasta (04.01.2018)

Student will be able to understrand the following:

Basic principles of management system in production of biomaterials.

Basic regulations connected with production of biomaterials.

Specific aspects of production of biomaterials.

Literature -
Last update: Pátková Vlasta (04.01.2018)

R: Zákon č. 123/2000 Sb. o zdravotnických prostředcích, v aktuálním znění.

R: Nařízení vlády ČR č. 336/2004 Sb., stanovení technických požadavků na zdravotnické prostředky, v aktuálním znění.

A: Buddy D. Ratner, Allan S. Hoffman, Frederick J. Schoen, Jack E. Lemons. Biomaterials Science: An Introduction to Materials in Medicine. 2dn edition, Academic Press, 2004.

Learning resources -
Last update: Pátková Vlasta (04.01.2018)

Learning materials are available by teacher.

Syllabus -
Last update: Pátková Vlasta (04.01.2018)

1. Certifications of producers of medical devices (ČSN EN ISO 13485, risk management)

2. Certifications of products � CE designation (93/42/EEC regulation)

3. Regulation of the applications of biomaterials in production of medical devices

4. Czech legislation connected with the production of medical devices from biomaterials

5. Research and development of medical devices from biomaterials

6. Industrial infrastructure in the production of medical devices

7. Basic requirements for the production inputs in the area of biomaterials

8. Assessment of the quality of biomaterials

9. Medical devices from metallic biomaterials

10. Medical devices from polymeric biomaterials

11. Medical devices from inorganic non-metallic biomaterials

12. Medical devices from composite and hybrid biomaterials and coatings

13. Sterilization, adjustation and distribution of biomaterials, vigilance system

14. Utility models, patents

Registration requirements -
Last update: Pátková Vlasta (04.01.2018)

Introduction to Study of Materials

 
VŠCHT Praha