Introduction

The Medical Device Regulation (MDR), particularly in the European Union, represents a paradigm shift in the regulatory landscape for medical devices, imposing significantly stricter requirements on manufacturers, importers, and distributors. With a heightened focus on patient safety, clinical evidence, post-market surveillance, and traceability, achieving and demonstrating MDR compliance is now more complex and critical than ever, impacting market access and business continuity. This essential training course focuses on Medical Device Regulation (MDR) Compliance Audit, equipping professionals with the critical knowledge and practical methodologies to rigorously assess an organization's adherence to these comprehensive new regulations, ensuring product safety, efficacy, and legal market entry. You will gain expertise in auditing the entire medical device lifecycle, from design and development to post-market activities, against the stringent requirements of the EU MDR (2017/745) and other relevant global standards.

This intensive training course delves into the core tenets of the Medical Device Regulation (MDR), including the General Safety and Performance Requirements (GSPR), clinical evaluation, technical documentation, quality management systems (QMS) under ISO 13485, and the roles of Notified Bodies and Economic Operators. We will explore various audit methodologies specifically tailored for MDR compliance, examining the adequacy of clinical evidence, the robustness of risk management processes, and the effectiveness of post-market surveillance plans. Participants will gain hands-on experience in planning, executing, and reporting on MDR compliance audits, identifying non-conformities, conducting root cause analysis for deficiencies, and formulating actionable recommendations to bridge compliance gaps. By the end of this training course, you will possess the expertise to confidently lead MDR compliance audit engagements, providing critical assurance and strategic guidance to navigate the evolving regulatory demands of the medical device industry.

Target Audience

• Medical Device Regulatory Affairs Professionals
• Quality Assurance & Quality Control Professionals
• Internal & External Auditors
• R&D and Product Development Managers (Medical Devices)
• Clinical Affairs Professionals
• Post-Market Surveillance Specialists
• Legal Counsel (Medical Devices)
• Risk Management Professionals in MedTech

Course Objectives

• Understand the fundamental concepts and objectives of the Medical Device Regulation (MDR).
• Learn about the key changes and stricter requirements introduced by the EU MDR (2017/745) compared to previous directives.
• Master methodologies for auditing compliance with General Safety and Performance Requirements (GSPR).
• Develop skills in assessing the adequacy of clinical evaluation and clinical evidence for medical devices.
• Understand the requirements for technical documentation under the MDR and how to audit it.
• Learn about techniques for auditing Quality Management Systems (QMS) specifically for MDR compliance (e.g., ISO 13485).
• Explore best practices for auditing post-market surveillance (PMS) and vigilance systems.
• Master techniques for assessing risk management processes in line with ISO 14971 and MDR.
• Understand the roles and responsibilities of Notified Bodies and Economic Operators under the MDR.
• Learn about preparing comprehensive MDR compliance audit reports and managing corrective actions.
• Apply practical Medical Device Regulation (MDR) Compliance Audit strategies to real-world scenarios.

Duration

5 Days

Course Content

Module 1: Introduction to the Medical Device Regulation (MDR)

• Defining the Medical Device Regulation (MDR) and its scope.
• Exploring the fundamental principles and objectives of MDR.
• Understanding the key changes from the Medical Devices Directive (MDD).
• Overview of the impact of MDR on manufacturers, importers, and distributors.
• The imperative for rigorous MDR compliance.

Module 2: General Safety & Performance Requirements (GSPR) Audit

• Learning the detailed General Safety and Performance Requirements (GSPR) of the MDR.
• Mastering methodologies for auditing GSPR compliance throughout the product lifecycle.
• Techniques for evaluating design and manufacturing processes against GSPR.
• Assessing biological safety, chemical properties, and infection control.
• Ensuring GSPR adherence for usability and performance.

Module 3: Clinical Evaluation & Post-Market Clinical Follow-up (PMCF) Audit

• Understanding the requirements for clinical evaluation and clinical data under MDR.
• Learning how to audit the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER).
• Mastering techniques for assessing Post-Market Clinical Follow-up (PMCF) activities.
• Evaluating the sufficiency of clinical evidence to demonstrate safety and performance.
• Ensuring continuous clinical evaluation throughout the device lifespan.

Module 4: Technical Documentation Audit

• Exploring the comprehensive requirements for technical documentation under MDR.
• Understanding the structure and content of the technical file.
• Mastering techniques for auditing the completeness, accuracy, and currency of technical documentation.
• Assessing risk management files (ISO 14971 compliance).
• Ensuring traceability from design to post-market data within the technical documentation.

Module 5: Quality Management System (QMS) & Auditing (ISO 13485 & MDR)

• Learning the integration of MDR requirements into an ISO 13485-compliant Quality Management System (QMS).
• Mastering techniques for auditing the QMS against MDR and ISO 13485.
• Assessing processes for management responsibility, resource management, and product realization.
• Evaluating control of outsourced processes and supplier quality.
• Ensuring the QMS effectively supports MDR compliance.

Module 6: Post-Market Surveillance (PMS) & Vigilance Audit

• Understanding the enhanced requirements for Post-Market Surveillance (PMS) under MDR.
• Learning about vigilance reporting obligations (e.g., serious incidents, field safety corrective actions).
• Mastering techniques for auditing PMS plans and data collection systems.
• Assessing the effectiveness of trend reporting and signal detection.
• Ensuring compliance with UDI (Unique Device Identification) and EUDAMED requirements for traceability.

Module 7: Audit Reporting, Non-Conformities & Continuous Improvement

• Strategies for planning and conducting effective MDR compliance audits.
• Mastering techniques for identifying, documenting, and classifying non-conformities.
• Preparing clear, concise, and actionable MDR compliance audit reports.
• Developing and tracking robust Corrective and Preventive Action (CAPA) plans.
• The role of audit in fostering continuous improvement and MDR readiness.

Training Approach

This course will be delivered by our skilled trainers who have vast knowledge and experience as expert professionals in the fields. The course is taught in English and through a mix of theory, practical activities, group discussion and case studies. Course manuals and additional training materials will be provided to the participants upon completion of the training.

Tailor-Made Course

This course can also be tailor-made to meet organization requirement. For further inquiries, please contact us on: Email: info@skillsforafrica.org, training@skillsforafrica.org  Tel: +254 702 249 449

Training Venue

The training will be held at our Skills for Africa Training Institute Training Centre. We also offer training for a group at requested location all over the world. The course fee covers the course tuition, training materials, two break refreshments, and buffet lunch.

Visa application, travel expenses, airport transfers, dinners, accommodation, insurance, and other personal expenses are catered by the participant

Certification

Participants will be issued with Skills for Africa Training Institute certificate upon completion of this course.

Airport Pickup and Accommodation

Airport pickup and accommodation is arranged upon request. For booking contact our Training Coordinator through Email: info@skillsforafrica.org, training@skillsforafrica.org  Tel: +254 702 249 449

Terms of Payment: Unless otherwise agreed between the two parties’ payment of the course fee should be done 10 working days before commencement of the training.