Certifying Active Medical Devices: A Practical Training Course for Compliance Teams (UTM) (Online / Remote)
1Summary
An active medical device can meet every engineering spec and still fail at the finish line if its certification file is not built the way regulators expect. That gap between good engineering and a successful submission is what this course, delivered by the Arab British Fellowship Training Academy, is designed to close for the people who design, manufacture, operate, and regulate active medical devices.
Rather than treating certification as a final paperwork step, the course walks through the standards, risk management, quality systems, and testing requirements that shape a device from its design phase through post-market surveillance, so participants can navigate approval processes such as CE marking and FDA clearance with fewer surprises.
2Objectives and target group
By the End of This Course, You Will Be Able To
- Classify active medical devices, understand their applications, and navigate the global regulatory landscape (FDA, EMA, WHO) and key international standards (ISO, IEC).
- Apply risk management principles, conduct risk assessments, and manage the certification and approval process, including CE marking and FDA premarket approval.
- Ensure devices meet safety, performance, and regulatory requirements through testing, clinical evaluation, and quality documentation.
- Build post-market surveillance and risk management strategies, including reporting, corrective actions, and cybersecurity considerations.
Who Should Attend?
- Biomedical engineers and quality control managers involved in developing, manufacturing, or maintaining active medical devices.
- Regulatory affairs professionals handling certification processes for medical devices.
- Medical device manufacturers, suppliers, and other professionals seeking to understand the regulatory requirements for active medical devices.
3Course Content
Module 1: The Regulatory Landscape and Where Your Device Fits
- Definition, classification, types, and key features of active medical devices.
- Global regulatory bodies (FDA, EMA, WHO), the regulatory framework, and key international standards (ISO, IEC).
- Device classification systems (Class I, II, III) and how classification drives certification requirements.
Module 2: Risk Management Across the Device Lifecycle
- Risk management principles for active medical devices, and conducting risk assessments and documentation.
- ISO 14971: its importance in managing risk, key principles, and methods for risk analysis and documentation.
- Ongoing risk assessment post-certification, corrective actions and recalls, and continuous monitoring and reporting.
Module 3: Quality Systems and Manufacturing Standards
- ISO 13485 and its application in active medical device certification, quality management system requirements, and document control, audits, and continuous improvement.
- Good Manufacturing Practices (GMP): requirements in production, implementation, and the role of quality control and inspection.
Module 4: Designing, Prototyping and Testing the Device
- Best practices for design control, documentation required during the design phase (design history file), and design validation.
- Methods of prototyping and early-stage testing, the role of testing in verifying safety and effectiveness, and clinical evaluation requirements.
Module 5: Meeting Essential Safety and Performance Requirements
- The role of CE marking and FDA approval, essential requirements for certification, and documentation and technical file preparation.
- Electromagnetic compatibility (EMC) requirements, testing methods, and addressing interference and safety risks.
- Types of safety tests, performance testing, and an overview of international testing standards.
- IEC 60601-1: its importance, key safety requirements for electrical medical devices, and testing and conformity assessment.
Module 6: Clinical Evaluation and Testing
- Requirements for clinical trials, methods for evaluating device performance and safety, and documentation and reporting of results.
- The role of in-vitro and in-vivo testing, best practices for performing these tests, and ethical considerations and regulatory oversight.
Module 7: Submitting for Certification and Navigating Approval
- The process for submitting devices for certification, preparing dossiers and technical documentation, and interaction with regulatory bodies.
- Key steps in the approval process, FDA premarket approval (PMA) and CE marking, and common obstacles and how to overcome them.
Module 8: Life After Certification: Surveillance, Audits and CAPA
- Importance of post-market surveillance, reporting adverse events, managing complaints, and post-market monitoring and device tracking.
- Conducting internal and external audits, and preparing for inspections by regulatory bodies.
- Implementing CAPA procedures, preventing future issues, and documenting corrective actions and follow-up.
Module 9: Cybersecurity and Sustainability Considerations
- Importance of cybersecurity in active medical devices, implementing secure systems, and regulatory requirements for device cybersecurity.
- Environmental concerns in development, best practices for sustainable design, and regulatory guidelines for sustainability.
Module 10: Where the Industry Is Heading
- Innovative technologies shaping the future of active medical devices, including AI, robotics, and wearables.
- The impact of new technologies on certification and regulatory processes.
- How global regulations are evolving, harmonization of standards across regions, and the future of certification and safety.