Basis of European Regulatory Affairs for Medical Devices Current Status Not Enrolled Price CHF90 CHF Get Started orLogin Gain a fundamental insight into the European regulatory framework for medical devices focusing on legal basis Course Content Expand All Chapter 1: European Regulatory Framework 4 Topics | 1 Quiz Expand Lesson Content 0% Complete 0/4 Steps What is Regulatory Affairs? European Legal Basis European Regulatory Trend CE Marking Quiz_ European Regulatory Framework Chapter 2: Classification of Medical Device 10 Topics | 1 Quiz Expand Lesson Content 0% Complete 0/10 Steps Definition Impact of Classification Classification Rules Classification Flow Practical Example: Classification of Medical Device Drug-device Combination Products Borderline Products Categories of Medical Device Software Classification Flow of Medical Device Software Practical Example: Classification of Medical Device Software Quiz_ Classification of Medical Device Chapter 3: Conformity Assessment 8 Topics | 1 Quiz Expand Lesson Content 0% Complete 0/8 Steps Essential Elements of Conformity Assessment Conformity Assessment of the QMS Conformity Assessment of Device Safety and Performance Conformity Assessment Procedures Special Additional Conformity Procedure- Scrutiny Procedure Special Conformity Procedure for Drug-device Combination Product Device with Tissues or Cells of Human & Animal Origin Conformity Assessment Means Quiz_ Conformity Assessment
