Topic 1: ISO 13485 – MEDICAL DEVICE QUALITY MANAGEMENT SYSTEMS Topic 2: 3-HOUR VIRTUAL SEMINAR ON 510(K) AND PMA SUBMISSIONS PROCESS
This exclusive Pack of webinars contain 5 courses: 1. IEC 62304 for Medical Device Software 2. Drafting a Software V&V Documentation Package and Protocol 3. Validation of Non-Product Software 4. IEC 62304 and Demystifying Software Validation using the Principles of LDLC 5. Medical Device Cybersecurity and FDA Compliance Total Duration: 10 Hours
This exclusive Pack of webinars contain 7 courses: 1. Laboratory Controls – Anticipate the Systems Based FDA Inspection 2. Analytical Method Validation and Transfer 3. Auditing Laboratory Data Systems 4. Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance 5. Handling OOS Test Results and Completing Robust Investigations 6. Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries 7. Establishing a Product Stability Testing Program Total Duration: 12 Hours