EU Medical Device Regulation (EU MDR) - Chapters 6 to 10 (ELM-328)
 | Method of Training: Online / Self-paced eLearning. Credits: 0.1 CPD Credits.Duration: ~60 minutes. Self-paced Training: 24/7 access to course. Enrollment Period: 3 months.  Catalog: Medical Device Regulatory Affairs.Demonstration: Try one of our FREE courses. Certificate: View sample certificate. PRICE: USD $199.00 |
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute. Training Program: EU Medical Device Regulation (EU MDR) - Chapters 6 to 10Training Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon ordering. Description: Online training with immediate access upon enrollment.  The objective of this course is to provide you with an overview of the EU MDR 2017/745. This overview will guide you through the following the background of the EU MDR, why it was introduced, the EU MDR structure and timeline, the main differences between MDD and MDR, an overview of each chapter and some of the key challenges facing organizations due to its introduction. It is designed to provide the student with a high-level comprehension of the regulation and what it means for organizations in today's world of medical device manufacture.Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements. EU Medical Device Regulation (EU MDR) - Chapters 6 to 10 course is included in the following Professional Certification Programs:
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COURSE OUTLINE:Introduction Overview Introduction Learning Objectives for this Overview The Background of the EU MDR 2017/745 1901 - Jim the Horse Tetanus Scandal 1959 - Primodos 1996 - ISO 13485 Medical Devices - Quality Management Systems 2018 - Vaginal Mesh Implants A Regulatory Evolution Introduction to EU MDR The Regulation Chapters and Articles Annexes The EU MDR Timeline What this means MDD vs MDR Chapters VI to X Chapter VI Clinical Evaluation Conduct of a Clinical Investigation Informed Consent Coordinated Assessment Procedure for Clinical Investigations Implementing Acts Chapter VII Post-Market Surveillance System of the Manufacturer PMS Report Reporting of Serious Incidents and Field Safety Corrective Trend Reporting Chapter VIII Competent Authorities Medical Device Coordination Group (MDCG) Chapter IX Confidentiality Data Protection Penalties Chapter X Committee Procedure Exercise of the Delegation Industry Pain Points Product Rationalization Notified Body Capacity Economic Operators - Supply Chain Impact Restricted Substances Claims Management Post Market Surveillance & Vigilance Post Market Surveillance Vigilance Clinical Evidence Labelling, IFUs, Patient cards and Layman's language IT Systems Conclusion Final Assessment Certification | COURSE OBJECTIVES:Skill Level: Intermediate This training program has been developed to train employees with Intermediate Knowledge of The European Union Medical Device Regulation (EU MDR). | |
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