Lectures and Exercises
1.First hour
• Laws on Medical Devices
2. Basic Documents
• MDD, Relevant Standards, EC Directive, MEDDEV
3.Registration and Certification of Medical Devices in the EU
• Requirements, Procedure
4.Management of medical devices from the point of view of the hospital
• MDD 2017/745, SÚKL, VZP, Notified Body, Notification, Accreditation
5.Management of health products from the manufacturer\'s perspective
• MDD 2017/745, SÚKL, VZP, Notified Body, Certification, Registration, Declaration of Conformity
6.Management system for manufacturers
• Structure, Application of EN ISO 13485: 2016, PMS, PMCF, Document updates
7-8.Technical documentation
• Technical Component, Conformity Assessment, Usability of Medical Devices, Medical Device Instruction, Testing of Medical Devices, Validation and Verification of the Life Cycle of a Medical Device, Validation and Verification of Software
9. Clinical evaluation of medical devices
• Preclinical Evaluation, Clinical Evaluation, Clinical Evaluation Plan, Ethics Committee
10.Biological evaluation
• Biological assessment plan, ČSN EN ISO 10993, Biocompatibility
11. Risk management and risk analysis for medical devices
• Content of the standard ČSN EN ISO 14971: 2012
12-14.Registration of medical devices outside the EU
• FDA, ASIA, SOUTH AMERICA, AUSTRALIA
1.First hour
• Laws on Medical Devices
2. Basic Documents
• MDD, Relevant Standards, EC Directive, MEDDEV
3.Registration and Certification of Medical Devices in the EU
• Requirements, Procedure
4.Management of medical devices from the point of view of the hospital
• MDD 2017/745, SÚKL, VZP, Notified Body, Notification, Accreditation
5.Management of health products from the manufacturer\'s perspective
• MDD 2017/745, SÚKL, VZP, Notified Body, Certification, Registration, Declaration of Conformity
6.Management system for manufacturers
• Structure, Application of EN ISO 13485: 2016, PMS, PMCF, Document updates
7-8.Technical documentation
• Technical Component, Conformity Assessment, Usability of Medical Devices, Medical Device Instruction, Testing of Medical Devices, Validation and Verification of the Life Cycle of a Medical Device, Validation and Verification of Software
9. Clinical evaluation of medical devices
• Preclinical Evaluation, Clinical Evaluation, Clinical Evaluation Plan, Ethics Committee
10.Biological evaluation
• Biological assessment plan, ČSN EN ISO 10993, Biocompatibility
11. Risk management and risk analysis for medical devices
• Content of the standard ČSN EN ISO 14971: 2012
12-14.Registration of medical devices outside the EU
• FDA, ASIA, SOUTH AMERICA, AUSTRALIA