Standards and quality in healthcare - KATI9M14

Goal(s)

The aim is to outline the principles of a quality management approach, introduce digital medical devices (industrial sectors, definitions, and regulatory status of medical devices), and explain the regulatory framework (stakeholders, notified bodies, and standardization processes), all while providing an understanding of the quality assurance concepts related to a device’s lifecycle, from its development through to market authorization.

This lecture consists of e-learning courses and tutoring to answer questions regarding the e-learning content.

Content(s)

1) Medical Device Regulations

• Overview of the MDR 2017/745
• Requirements of the MDR 2017/745
• Quality and risk management in healthcare

2) Standards for Medical Devices

• Introduction to the various standards
• ISO 13485 - Medical Device Quality Management System
• ISO 14971 - Medical Device Risk Management
• ISO/IEC 62366 - Usability
• ISO/IEC 62304 - Software
• ISO 10993 - Preclinical Evaluation
• ISO 14155 - Clinical Evaluation

3) Medical Device Topology

• Classification of Medical Devices
• Connected Medical Devices
• DMDIV
• Examples of Clinical Applications for Connected Medical Devices

4) Medical Device Lifecycle

• Economic Operators
• Notified Bodies
• Obtaining CE Marking
• Audit
• Medical Device Vigilance
• Market Access
• Control of Suppliers and Subcontractors
• QMS Example

Calendar

The course exists in the following branches:

• Curriculum - TIS - Semester 9

Additional Information

Course ID : KATI9M14
Course language(s):

You can find this course among all other courses.