The European Union's Medical Device Regulations (EU MDR) represent a complex and comprehensive framework governing the lifecycle of medical devices in the EU market. Covering every stage from design and development to post-market surveillance, these regulations impose rigorous standards to guarantee the safety and effectiveness of devices making it difficult for industry leaders to stay updated and achieve compliance.
This certified program will provide you with an in-depth understanding of the intricate and evolving EU medical device regulations to help you stay compliant on the regulatory changes. You will explore a broad spectrum of essential topics, including intricate aspects into the EU’s Medical Device Regulations frameworks, conformity assessment procedures, clinical evaluation requirements, post-market surveillance, and vigilance. This comprehensive coverage will enable you to grasp the legal and operational facets of bringing medical devices to the EU market and help you stay compliant with the latest regulatory framework.
Throughout the program, you will gain knowledge in critical areas such as risk management, technical documentation, labelling requirements, and unique device identification (UDI) systems. You will also gain insights into the roles and responsibilities of notified bodies and the impact of harmonized standards on your compliance strategy. Additionally, this program will equip you with the skills to develop and implement robust quality management systems (QMS) aligned with ISO 13485 and ISO 14971 standards, conduct clinical investigations, and prepare for regulatory audits. You will learn to anticipate and adapt to regulatory changes, ensuring your organization remains compliant and competitive in the dynamic EU medical device market.
Upon successful completion of the program, you will attain the Certification in EU Medical Device Regulations and Compliance. This distinguished certification will demonstrate your expertise in EU MDR implementation, quality management, and regulatory strategy, significantly enhancing your professional practice and standing in the field. Globally demanded and recognized, this industry-recognized certification also holds lifelong validity empowering you to make informed decisions and implement best practices in the rapidly evolving medical device sector.
1 Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.
This program will entitle you:
Download Brochure Pricing & Registration- Experience 2 days of instructor-led live training and delve into the comprehensive EU regulatory landscape, including the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), the complexities of medical device qualification, and the roles of notified bodies and conformity assessments.
- Attain the industry-recognized Certification in EU Medical Device Regulations and Compliance. This certification enhances your qualifications, showcasing your expertise in EU medical device regulations and your ability to navigate compliance, quality management, and clinical requirements across Europe.
- Master ISO 13485:2016 and ISO 14971 implementation, integrate them with MDR requirements, and ensure compliance with evolving EU standards through effective risk management and post-market surveillance.
- For inquiries, chat with our Program Advisers at advisor@charteredcertifications.com or call us at
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- USA: +1 888 745 8875
Accreditations
This program is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all professionals who have completed this program.
The content of this program has been fully certified and accredited by CPD Certification Service as conforming to Continuing Professional Principles. CPD is the leading independent CPD accreditation institution operating across industry sectors to complement the Continuing Professional Development policies of professional institutes and academic bodies. The CPD Certification Service provides support, advice and recognized independent CPD accreditation compatible with global CPD principles.
What Can You Expect From This Live Program
The transition to the EU Medical Device Regulation (MDR) increased essential requirements from 18 to 22 classification rules, complicating compliance for manufacturers. This expansion, aimed at enhancing safety and effectiveness, demands more resources and poses significant challenges in maintaining consistent market access across the EU.
This certified program is designed to equip you with essential skills for effective regulatory management and compliance in the medical device industry. This comprehensive program covers intricate aspects of EU Medical Device Regulation (MDR) implementation, quality management systems, and clinical evidence requirements, enabling you to navigate complex regulatory landscapes with confidence and expertise. Through an in-depth exploration of topics such as the fundamental principles of device classification, conformity assessment procedures, and risk management strategies, you will enhance your regulatory understanding and refine your ability to ensure product safety and compliance.
The program will also offer invaluable insights into technical documentation preparation, post-market surveillance techniques, and the nuances of interactions with notified bodies. Additionally, you will learn effective methods for clinical evaluation, use of the European database on medical devices (EUDAMED) database, and techniques to demonstrate conformity with General Safety and Performance Requirements (GSPR) while addressing regulatory challenges, thereby crafting robust compliance strategies.
Moreover, this program will provide you with comprehensive guidance on ISO 13485 and ISO 14971 standards, aligning them with specific MDR requirements and exploring strategies for implementing effective Quality Management Systems (QMS) and risk management. Finally, you will learn about the clinical evaluation process, including the establishment of state-of-the-art practices, planning for conformity, and the continuous collection of clinical evidence throughout the device lifecycle.
Upon successful completion of the program, you will receive the Certification in EU Medical Device Regulations and Compliance, enhancing your professional credentials and demonstrating your mastery in ensuring product safety, efficacy, and regulatory adherence. This industry-recognized certification which offers lifelong validity not only boosts your professional profile but also prepares you to handle the complexities of EU medical device compliance with confidence and expertise.
Key Skills You Will Gain
- Medical Devices Directive (MDD)
- Medical Devices Regulations (MDR) Compliance IVDR Understanding
- Device Classification
- Risk Assessment
- Quality Management ISO 13485 Compliance
- ISO 14971 Application
- Clinical Evaluation
- Regulatory Submissions
- Quality Management Systems (QMS)
- Notified Body Interaction
- Technical Documentation
- Post-Market Surveillance
- Adverse Event Reporting
- EUDAMED Data Management
- Clinical Development Plan (CDP)
- Declaration of Conformity (DoC) Post-Market Clinical Follow-Up (PMCF)
- Unique Device Identification (UDI) System
- Person Responsible for Regulatory Compliance (PRRC)
- CE (Conformité Européenne) Mmarking
- Field Safety Corrective Actions (FSCA)
- Conformity Assessment
- Standard of Care (SoC)
Your Faculty Director
Asha Jacob is a distinguished leader in regulatory affairs and compliance within the MedTech industry, boasting an impressive 18-year career. Her expertise spans across R&D, regulatory affairs, clinical affairs, medical writing, quality assurance, and quality management. Currently, she serves as the Head of the Regulatory Affairs and Compliance team at Philips Medical Systems in the Netherlands. Asha also holds the crucial roles of EU Authorized Representative Officer for EU MDR & EU IVDR and Person Responsible For Regulatory Compliance-2 at Philips.
Asha's holistic, cross-functional understanding of EU MDR has enabled her to guide both business and market organizations through regulatory complexities. Her expertise is further validated by BSI training in MDR Implementation for CE Marking and CQI & IRCA ISO 13485:2016 Auditor/Lead Auditor Certification, underscoring her commitment to maintaining the highest standards in regulatory affairs and compliance.
EU Medical Device Regulations and Compliance Program Agenda
How You Will Benefit
- Grasp the Medical Device Regulations Evolution: Understand the transition from MDD to MDR, focusing on historical context and regulatory milestones.
- Analyze MDR Changes: Explore detailed changes introduced by the MDR and their implications for medical device regulation.
- Impact Assessment: Examine the implications of MDR for manufacturers, notified bodies, and other stakeholders.
- Enhance Device Safety: Learn how MDR focuses on improving safety, performance, patient outcomes, transparency, and traceability.
- Navigate Transition Timelines: Review current implementation statuses and tackle associated challenges.
- Master CE Marking: Gain insights into the CE marking process and various conformity assessment routes.
- Understand Device Classification: Learn about the classification criteria for medical devices and in vitro diagnostics.
- Manage Risk Classification: Analyze how risk classification impacts conformity assessments.
- Mastering ISO 13485 Standards: Understand the importance of ISO 13485 in quality management systems for medical device manufacturers.
- Risk Management with ISO 14971: Dive deep into the risk management processes using ISO 14971.
Certification in EU Medical Device Regulations and Compliance
Upon successfully attending this program, you will be awarded with the Certification in EU Medical Device Regulations and Compliance that can be used in your resume, CV and other professional credentials. This certification is industry-recognized with lifelong validity. Globally demanded and recognized, this certification underscores your expertise in managing complex regulatory environments, elevating your professional standing and effectiveness in ensuring medical device compliance across international markets. This program is developed by Chartered Institute of Professional Certifications and the content of this program has been certified by CPD Certification Service as conforming to continuing professional principles.
Pricing & Registration
Europe
Dates: 26 - 27 Feb 2025
Venue: Online Executive Program (via Zoom)
Time: 9:00am - 4:30pm Greenwich Mean Time (GMT)
10:00am - 5:30pm Central European Time (CET)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 06 Jan 2025 | By 17 Feb 2025 | After 17 Feb 2025 | |
| EU Delegates | EUR 1,295 | EUR 1,495 | EUR 1,595 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)
Register NowDownload Brochure
You can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at advisor@charteredcertifications.com or call us at:
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- USA: +1 888 745 8875
EU Medical Device Regulations and Compliance Reviews and Testimonials
Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.
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EU Medical Device Regulations and Compliance
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