Description

This structure ensures that participants gain both theoretical knowledge and practical skills in managing the lifecycle of medical devices, ensuring compliance with global standards, and preparing for real-world challenges.

Module 1: Introduction to Medical Devices and Regulatory Bodies

• Overview of Medical Devices and their classifications
• Global health authorities and their roles: FDA (US), MHRA (UK), EMA (EU)
• Notified bodies and authorized representatives in medical device certification

Module 2: Regulatory Frameworks and Compliance (EU, UK, US)

• Registration of Medical Devices and preparing technical dossiers
• UK MDR 2022 and UKCA marking process
• EU MDR 2017/745 and CE marking
• FDA clearance and approvals for medical devices (510(k) and PMA)

Module 3: Quality Management Systems and Risk Analysis

• Introduction to ISO 13485 (Quality Management Systems for Medical Devices)
• ISO 14971: Risk Management in medical device manufacturing
• Overview of EC 60601 family compliance for electrical medical devices

Module 4: Technical Files, Documentation, and SOPs

• Preparation and updates of technical files, procedures, and reports
• Declarations of conformity and alignment with regulatory frameworks
• Development and review of SOPs and working instructions

Module 5: Post-Market Surveillance (PMS) and Vigilance

• Compilation of PMS and PSUR reports
• Managing device lifecycle through system database updates
• Timelines and documentation for vigilance reporting and CAPA

Module 6: Cross-Functional Team Management and Global Submissions

• Collaboration with cross-functional teams (R&D, Regulatory, QA, Marketing)
• Requirements for worldwide submissions of medical devices
• Tracking and reconciliation of investigational product (IP) and trial materials

Module 7: Certifications, Markings, and Compliance Audits

• Overview of UKCA, CE marking, and EU MDD 93/42/EEC compliance
• Preparing for audit inspections and compliance assessments
• Importance of ETL/UL marking for electrical and electronic devices

Module 8: Final Assessment and Career Preparation

• Mock assessment and feedback session
• CV building and interview preparation for careers in medical devices
• Career pathways: Regulatory Affairs, Quality Management, and Clinical Research