Essentials of European Medical Device Regulations Level 1

Training Excellence

• Essentials of European Medical Device Regulations Level 1 1:25:41

  • 1: Introduction to European Medical Device Regulations 18:47
  • 2: Secure Your Certificate Early 01:00
  • 3: Essentials Components of EU MDR 23:30
  • 4: Requirements for Design and Manufacture of Medical Devices 15:20
  • 5: Requirements for Identification, Traceability and Reporting Adverse Events 12:41
  • 6: Quality Management System for Medical Devices for EU MDR 10:23
  • 7: Self Assessment 03:00
  • 8: Congratulations on Course Completion 01:00

• UK Medical Law 43:00

  • 9: UK Medical Law 43:00

• Health and Safety at Work 34:00

  • 10: Health and Safety at Work 34:00

• First Aid at Workplace 43:00

  • 11: First Aid at Workplace 43:00

Course 1: Essentials of European Medical Device Regulations Level 1

Section 1: Understanding the Basics of European Medical Device RegulationsLecture 1: Introduction to European Medical Device Regulations

• What Is the European Union Medical Device Regulation?
• EU Directives of Medical Devices
• The Impact of Medical Device Regulations in the European
• Terms and Definition of EU Medical Device Regulations

Section 2: Technical Documentation RequirementsLecture 2: Essentials Components of EU MDR

• Technical Documentation of Medical Devices
• Classification Rules for Medical Devices
• Clinical Evidence and Post-Market Surveillance

Section 3: Essential Design and Manufacturing Requirements for Medical DevicesLecture 3:Requirements for Design and Manufacture of Medical Devices

• Chemical, Physical and Biological Properties
• Design and Manufacture of devices
• Justification of the Presence of CMR and Endocrine-Disrupting Substances
• Follow Guidelines on Phthalates and Endocrine-disrupting Substances
• Labelling
• Infection and Microbial Contamination
• Protection from Radiation
• Particular Requirements for Active Implantable Devices
• Protection against Mechanical and Thermal Risks
• Protection against Devices Supplying Energy or Substances
• Protection against Devices Intended by the Manufacturer for Use by Lay Persons

Section 4: Medical Devices Identification, Traceability and Reporting Adverse EventsLecture 4: Requirements for Identification, Traceability and Reporting Adverse Events

• Unique Device Identifier for the Traceability of Medical Device
• European Database on Medical Devices (EDUAMED)
• Reporting Procedures for Adverse Events

Section 5: EU Regulations for the Quality Management of Medical DevicesLecture 5: Quality Management System for Medical Devices for EU MDR

• Medical Device Quality Management System (QMS)
• International Standards and Regulations for Medical Device QMS
• How to Implement Quality Management Systems on Medical Devices
• Quality Management System for EU MDR

Course 2: Uk Medical Law
Course 3: Health and Safety at Work

Course 4:First Aid at Workplace

This course is specially designed for those who want to start or advance in their career as:

• Professionals involved in manufacturing medical devices
• Importers of medical devices into the EU
• Authorised representatives of medical devices in the EU
• Regulatory affairs specialists
• Quality assurance professionals
• Anyone seeking to understand EU MDR

There is no prerequisite for this. Don’t worry—we will teach you everything step by step.

Here are the job options in the UK for this course:

• Medical Device Compliance Specialist

• Regulatory Affairs Officer / Associate

• Quality Assurance (QA) Specialist

• Health and Safety Officer / Coordinator

• First Aid & Workplace Safety Trainer

• Clinical / Healthcare Support Roles (with compliance focus)

• Medical Device Consultant