EU MDR: EU Medical Device Regulation - Chapters 6 to 10
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Download Saturday, May 16, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline: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 | 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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Since 2003, Biopharma Institute has helped professionals and their employers meet training requirements. Our certifications are recognized by a wide range of industries, regulatory bodies, and organizations worldwide. Training solutions can be customized to meet the needs of any organization. We currently offer over 300 courses covering topics such as clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity, serving the clinical research, pharmaceutical, and medical device sectors.
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