The Active Medical Devices Certification Course (UTM), offered by the British Academy for Training and Development, is designed for professionals involved in the design, manufacture, operation, and regulation of active medical devices. This course provides in-depth knowledge of the essential standards, regulations, and best practices for ensuring the safety, performance, and compliance of medical devices that rely on electrical power to function, such as diagnostic and therapeutic devices. Participants will learn to navigate the certification process, address key regulatory requirements, and ensure that medical devices meet international safety standards.

Who Should Attend?

• Biomedical engineers involved in the development and maintenance of active medical devices.
• Regulatory affairs professionals working with medical devices and their certification processes.
• Medical device manufacturers and suppliers seeking compliance with international standards.
• Quality control managers and technicians in medical device companies.
• Professionals seeking to understand the regulatory requirements for active medical devices.

Knowledge and Benefits:

After completing the program, participants will be able to master the following:

• Understand the various types of active medical devices and their application in healthcare settings.
• Gain knowledge of the international standards and regulations governing active medical devices.
• Navigate the process of certification and approval of active medical devices.
• Ensure active medical devices comply with safety, performance, and regulatory requirements.
• Develop strategies for risk management and post-market surveillance of active medical devices.
• Understand the role of testing, validation, and documentation in the certification process.

• Overview of Active Medical Devices
  • Definition and classification of active medical devices.
  • Types of active medical devices used in healthcare.
  • Key features and functionality of active medical devices.
• Regulatory Landscape for Active Medical Devices
  • Introduction to global regulatory bodies (FDA, EMA, WHO).
  • Overview of the regulatory framework for medical devices.
  • Key international standards for medical devices (ISO, IEC).

• Medical Device Classification and Risk Management
  • Understanding device classification systems (Class I, II, III).
  • Risk management principles for active medical devices.
  • Conducting risk assessments and documentation.
• Essential Requirements for Certification
  • The role of CE marking and FDA approval.
  • Essential requirements for medical device certification.
  • Documentation and technical file preparation.

• ISO 13485 Standards for Medical Devices
  • Introduction to ISO 13485 and its application in active medical device certification.
  • Key requirements for implementing an effective quality management system.
  • Document control, audits, and continuous improvement processes.
• Good Manufacturing Practices (GMP)
  • Overview of GMP requirements in medical device production.
  • Implementing GMP in the production of active medical devices.
  • Role of quality control and inspection in ensuring compliance.

• Design Control and Documentation
  • Best practices for design control in the development of medical devices.
  • Documentation required during the design phase (design history file).
  • Risk management and design validation.
• Prototyping and Testing
  • Methods of prototyping and early-stage testing.
  • The role of testing in verifying device safety and effectiveness.
  • Design validation and clinical evaluation requirements.

• Submission for Certification
  • The process for submitting active medical devices for certification.
  • Preparing submission dossiers and technical documentation.
  • Interaction with regulatory bodies during the approval process.
• Navigating the Approval Process
  • Key steps in the certification approval process.
  • FDA premarket approval (PMA) and CE marking process.
  • Common obstacles and how to overcome them during certification.

• Post-Market Surveillance Requirements
  • Importance of post-market surveillance in ensuring ongoing device safety.
  • Reporting adverse events and managing complaints.
  • Techniques for post-market monitoring and device tracking.
• Managing Risks After Certification
  • Strategies for ongoing risk assessment post-certification.
  • Implementing corrective actions and recalls if necessary.
  • Continuous monitoring and reporting.

• Electromagnetic Compatibility (EMC) Requirements
  • Understanding EMC requirements for active medical devices.
  • Testing methods for verifying EMC compliance.
  • Addressing interference and safety risks related to electromagnetic fields.
• Safety and Performance Testing
  • Types of safety tests required for active medical devices.
  • Performance testing to ensure reliability and compliance.
  • Overview of international testing standards for medical devices.

• ISO 14971: Risk Management
  • The importance of ISO 14971 in managing risks in medical devices.
  • Key principles of risk management for active medical devices.
  • Methods for conducting risk analysis and documentation.
• IEC 60601-1: Medical Electrical Equipment
  • Understanding IEC 60601-1 and its importance in medical device certification.
  • Key safety requirements for electrical medical devices.
  • Testing requirements and conformity assessment.

• Clinical Evaluation of Medical Devices
  • Requirements for clinical trials in active medical devices.
  • Methods for evaluating device performance and safety in clinical settings.
  • Documentation and reporting of clinical trial results.
• In-vitro and In-vivo Testing
  • The role of in-vitro and in-vivo testing in the evaluation process.
  • Best practices for performing these tests.
  • Ethical considerations and regulatory oversight.

• Surveillance Audits for Active Medical Devices
  • Conducting audits to ensure compliance with regulatory standards.
  • Internal and external audit processes for active medical devices.
  • Preparing for inspections by regulatory bodies.
• Corrective and Preventive Actions (CAPA)
  • Implementing CAPA procedures for identified non-conformities.
  • Strategies for preventing future issues and ensuring continuous improvement.
  • Documenting corrective actions and follow-up activities.

• Cybersecurity Considerations for Medical Devices
  • Understanding the importance of cybersecurity in active medical devices.
  • Implementing secure systems to protect device data.
  • Regulatory requirements for device cybersecurity.
• Sustainability and Environmental Impact
  • Environmental concerns in the development of medical devices.
  • Best practices for designing sustainable and environmentally friendly devices.
  • Regulatory guidelines for sustainability in medical devices.

• Emerging Technologies in Active Medical Devices
  • Innovative technologies shaping the future of active medical devices.
  • The role of AI, robotics, and wearable technologies in medical devices.
  • Impact of new technologies on certification and regulatory processes.
• Global Trends in Medical Device Regulation
  • How global regulations are evolving.
  • Harmonization of regulatory standards across different regions.
  • The future of medical device certification and safety.