Technical Documentation Current Status Not Enrolled Price CHF85 CHF Get Started orLogin Best practices to compile technical documentation for cross-regional regulatory purposes Course Content Expand All Technical Documentation 9 Topics | 1 Quiz Expand Lesson Content 0% Complete 0/9 Steps Chapter 1: Common Format and Structure of Technical Documentation Chapter 2: Content of Technical Documentation Chapter 3: Module 1- Regional Administrative Chapter 4: Module 2- Submission Context Chapter 5: Module 3 Non-clinical Evidence Chapter 6: Applying ISO Standards to Meet MDR Requirements Chapter 7: Module 4- Clinical Evidence Chapter 8: Module 5- Labelling Information and Promotional Material Chapter 9: Module 6A, 6B- Quality Management System Quiz_ Technical Documentation Risk Management File 4 Topics | 1 Quiz Expand Lesson Content 0% Complete 0/4 Steps Introduction into Risk Management Risk Management Plan Risk Analysis Risk Management Report Quiz_ Risk Management File
