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Lessons
| Name | Course | Watched | Assessments | |
|---|---|---|---|---|
| Introduction - Qualification | Regulatory Basics: Is your product a medical device? | Not available in current plan.. | Book a free demo | |
| Intended Use and Intended Purpose | Regulatory Basics: Is your product a medical device? | Not available in current plan.. | Book a free demo | |
| Classification | Regulatory Basics: Is your product a medical device? | Not available in current plan.. | Book a free demo | |
| General Safety and Performance Requirements | Regulatory Basics: Is your product a medical device? | Not available in current plan.. | Book a free demo | |
| Welcome | An introduction to the legal system according to MDR | Not available in current plan.. | Book a free demo | |
| Introduction | An introduction to the legal system according to MDR | Not available in current plan.. | Book a free demo | |
| Essential requirements | An introduction to the legal system according to MDR | Not available in current plan.. | Book a free demo | |
| Classification | An introduction to the legal system according to MDR | Not available in current plan.. | Book a free demo | |
| Conformity assessment | An introduction to the legal system according to MDR | Not available in current plan.. | Book a free demo | |
| Unique Device Identification | An introduction to the legal system according to MDR | Not available in current plan.. | Book a free demo | |
| Clinical Evaluation & PMCF | An introduction to the legal system according to MDR | Not available in current plan.. | Book a free demo | |
| Post Market Surveillance | An introduction to the legal system according to MDR | Not available in current plan.. | Book a free demo | |
| Roles | An introduction to the legal system according to MDR | Not available in current plan.. | Book a free demo | |
| Quality Management | An introduction to the legal system according to MDR | Not available in current plan.. | Book a free demo | |
| About this series | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Basic principles | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| The route to the QM-System | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Standards and regulations | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| QMM 1: Quality Policy | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| QMM 2: Quality objectives | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Roles and responsibilities 01: Fundamentals | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Roles and responsibilities 02: Regulations | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Roles and Responsibilities 3: QM Representative | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Processes and procedures | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Compiling lists of SOPs | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Writing SOPs | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Writing SOPs II | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| How to write SOPs? | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| SOP review, communicate, train | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Basics | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Regulations | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Determining measures | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Writing SOPs | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Introduction | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| ISO 13485 | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| ISO 9001:2015 | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| IEC 62366-1:2015 | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| IEC 60601-1 | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| IEC 62304 | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Writing options | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Structure | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| SOP on Risk Management | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Synchronize development process | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Management review regulations | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Writing management review SOPs | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Introduction | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Regulations | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Writing SOPs | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Introduction | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Regulations | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Writing SOPs | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Introduction | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Regulations | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Vigilance | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| CAPA | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Training 1: Introduction | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Training 2: Regulations | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Training 3: SOP on training | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Production 1: Introduction | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Production 2: Blackbox | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Production 3: Production processes | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Production 4: Production risks | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Production 5: Risk control measures | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Production 6: Identification | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Production 7: Traceability | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Production 8: Stadard operating procedures | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Production 9: Production Audit | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Process Validation 1: Basics | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Process validation 02: IQ, PQ, OQ | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Process validation 3: regulations | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Storage & Transport 01: Introduction | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Storage & Transport 02: Measures | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Storage & Transport 3: Risk Management | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Storage & Transport 04: Regulations | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Sales 1: Intro | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Sales 2: Risks | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Sales 3: Actions and SOPs | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Sales 4: Regulatory requirements | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Infrastructure: Part 1 Introduction | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Infrastructure: Part 2 Requirements | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Infrastructure: Part 3 Maintenance activities and documentation | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Measuring equipment 1: Introduction | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Measuring equipment 2: Regulatory requirements 13485 (overview) | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Measuring equipment 3: Regulatory requirements 13485 (7.6 - Part 2 - Measuring equipment) | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Measuring equipment 4: Regulatory requirements 13485 (7.6. - Part 3 - Software) | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Measuring equipment 5: Regulatory requirements 13485 (procedure instruction) | Quality Management (ISO 13485) | Not available in current plan.. | Book a free demo | |
| Introduction | The person responsible for regulatory compliance | Not available in current plan.. | Book a free demo | |
| Regulations | The person responsible for regulatory compliance | Not available in current plan.. | Book a free demo | |
| Obligation to have a PRRC | The person responsible for regulatory compliance | Not available in current plan.. | Book a free demo | |
| Qualification | The person responsible for regulatory compliance | Not available in current plan.. | Book a free demo | |
| Responsibilities (overview) | The person responsible for regulatory compliance | Not available in current plan.. | Book a free demo | |
| Product release | The person responsible for regulatory compliance | Not available in current plan.. | Book a free demo | |
| Technical Documentation | The person responsible for regulatory compliance | Not available in current plan.. | Book a free demo | |
| Post Market Surveillance | The person responsible for regulatory compliance | Not available in current plan.. | Book a free demo | |
| Vigilance, Reporting 1 | The person responsible for regulatory compliance | Not available in current plan.. | Book a free demo | |
| Vigilance, Reporting 2 | The person responsible for regulatory compliance | Not available in current plan.. | Book a free demo | |
| Investigational devices | The person responsible for regulatory compliance | Not available in current plan.. | Book a free demo | |
| Finding PRRC | The person responsible for regulatory compliance | Not available in current plan.. | Book a free demo | |
| An introduction to risk management | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Definitions | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Risk assessment matrix: Introduction | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Risk acceptance matrix: X-Axis | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Risk assessment matrix: Y-Axis | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Risk assessment matrix: Acceptance Criteria | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Risk Analysis: General | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Risk Analysis: PHA | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Risk Analysis: FMEA | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Risk Analysis: FTA | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Risk Analysis: Software Specifics | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Risk Analysis: Probabilities | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Risk Control | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Risk management: Post Production | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Documentation and ISO 14971: Documentation | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| The standard for risk management: ISO 14971 | Risk management according to ISO 14971 | Not available in current plan.. | Book a free demo | |
| Introduction | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| Basics | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| Product categories | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| Basic UDI-DI | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| Regulatory requirements | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| Allocation and assignment of UDI | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| GS1 | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| HIBCC | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| UDI carrier | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| Application | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| Implants | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| Systems and procedure packs | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| IVDR | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| Configurable products | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| UDI and Software | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| New UDI | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| EUDAMED | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| FDA differences | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| Transition periods | The Unique Device Identification (UDI) | Not available in current plan.. | Book a free demo | |
| Software-lifecycle: Introduction | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software-Lifecycle: V-Model | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software requirements: Introductions | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software Requirements: User Interface | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software Requirements: Data Interface | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software Requirements: Other Interfaces | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software Requirements: Documentation, Verification | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software Architecture: Introduction | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software Architecture: Regulations | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software Architecture: Safety Classification | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software Architecture: Documentation & Verification | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software-Tests: Unit-Tests | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software-Tests: Integration Test | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software-Tests: System Test | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Software file: Release | The software development according to IEC 62304 | Not available in current plan.. | Book a free demo | |
| Basics: Introduction | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| Basics: Definition of terms | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| Basics: Regulations | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| Basics: Process | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| IEC 62366-1: Part 1 | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| IEC 62366-1: Part 2 - Subclause 5.1 | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| IEC 62366-1: Part 3 - Risk management | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| IEC 62366-1: Part 4 - UI specification | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| IEC 62366-1: Part 5 - UI Evaluation | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| IEC 62366-1: Part 6 - UOUP | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| IEC 62366-1: Part 7 - Documentation | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| Methods 1: Overview | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| Methods 2: Prototyping | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| Methods 3: Formative procedures | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| Methods 4: Usability tests | Usability engineering according to IEC 62366-1 | Not available in current plan.. | Book a free demo | |
| Goals of the series | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Basics | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Regulations: EU-MDR | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Regulation: EU-MDR-MDD | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Regulations: More EU | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Regulations: MEDDEV | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Omitting | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| General Concepts: Claims | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| General Concepts: Process | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| General Concepts:: Equivalence 1 | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| General Concepts: Equivalence 2 | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Planning: Regulations | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Planning: Documentation | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Planning: Evaluation criteria | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Literature: Sources | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Literature: Search | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Literature: Process | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Literature: Individual evaluation | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Literature: Conclusions | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Concepts: Medical Writing | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Concepts: Interfaces 1 | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Concepts: Interfaces 2 | Clinical evaluation according to MEDDEV 2.7/1 Rev 4 | Not available in current plan.. | Book a free demo | |
| Welcome | MDR for auditors | Not available in current plan.. | Book a free demo | |
| Scope | MDR for auditors | Not available in current plan.. | Book a free demo | |
| Chapter 2 | MDR for auditors | Not available in current plan.. | Book a free demo | |
| Annex I, Part 1 | MDR for auditors | Not available in current plan.. | Book a free demo | |
| Annex-I Software | MDR for auditors | Not available in current plan.. | Book a free demo | |
| Annex II | MDR for auditors | Not available in current plan.. | Book a free demo | |
| Classification | MDR for auditors | Not available in current plan.. | Book a free demo | |
| Conformity Assessment | MDR for auditors | Not available in current plan.. | Book a free demo | |
| Quality Management System | MDR for auditors | Not available in current plan.. | Book a free demo | |
| Post Market Surveillance | MDR for auditors | Not available in current plan.. | Book a free demo | |
| Roles | MDR for auditors | Not available in current plan.. | Book a free demo | |
| PLM-OEM | MDR for auditors | Not available in current plan.. | Book a free demo | |
| Computer System Validation - An introduction | Computer System Validation | Not available in current plan.. | Book a free demo | |
| Definitions 1 | Computer System Validation | Not available in current plan.. | Book a free demo | |
| Definitions 2 | Computer System Validation | Not available in current plan.. | Book a free demo | |
| Regulations: EU | Computer System Validation | Not available in current plan.. | Book a free demo | |
| Regulations: USA | Computer System Validation | Not available in current plan.. | Book a free demo | |
| Regulations: Rest of the world | Computer System Validation | Not available in current plan.. | Book a free demo | |
| The CSV process: Overview | Computer System Validation | Not available in current plan.. | Book a free demo | |
| The CSV process: Intended purpose and validation requirement | Computer System Validation | Not available in current plan.. | Book a free demo | |
| The CSV process: Criticality | Computer System Validation | Not available in current plan.. | Book a free demo | |
| The CSV process: The validation plan | Computer System Validation | Not available in current plan.. | Book a free demo | |
| The CSV process: Test specifications | Computer System Validation | Not available in current plan.. | Book a free demo | |
| The CSV process: The execution and documentation of tests | Computer System Validation | Not available in current plan.. | Book a free demo | |
| Overview | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Definitions | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Safety objectives | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Context | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Regulations: An overview | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Regulations: IT security and EU laws | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Regulations: Harmonized standards | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Regulations: FDA | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Analysis of vulnerabilities: Overview | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Analysis of vulnerabilities: Objects | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Analysis of vulnerabilities: Threats | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Vulnerability Analysis Methods: Checklists | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Vulnerability Analysis Methods: More checklists | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Vulnerability Analysis Methods: Your own data | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Vulnerability Analysis Methods: Input-output analysis | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Penetration testing: Procedure | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Penetration testing: Brute Force | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Penetration testing: Reverse Engineering | IT security for medical devices | Not available in current plan.. | Book a free demo | |
| Basics of AI: Goals | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Basics of AI: Introduction | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Basics of AI: Definitions | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Methods: Overview | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Methods: Linear regression | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Methods: Logistic regression | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Methods: Support Vector Machines | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Methods: Clustering | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Methods: Bayes | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Methods: Decision trees | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Methods: Random Forrests | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Methods: Neural Networks - Introduction | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Methods: Neural Networks - Image Recognition | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Methods: Neural Networks - Fit Parameters | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Regulations: EU - MDR | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Regulations: EU - MDR Annex I | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Regulations: EU - MDR Annex II + III | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Regulations: Harmonized standards | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Evaluation of algorithms: Challenges | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Evaluation of algorithms: Measures of quality 1 | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Evaluation of algorithms: Measures of quality 2 | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Explainable AI: Introduction | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Explainable AI: Stakeholders | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Explainable AI: Interpretability | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Explainable AI: Taxonomie | Artificial intelligence | Not available in current plan.. | Book a free demo | |
| Introduction | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 1.1: IVD qualification Regulatory framework, definitions, areas of application | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 1.2: Implementation rules for classification | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 1.3: Overview of tasks for approval under IVDR | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 1.4: How we know when conformity is achieved | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 2.1: Qualifying products as IVDs - comparison of intended purpose and IVD definition | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 2.2: The product types | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 2.3: Implementing the strategy - creating product-specific files | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 2.4: IVD conformity assessment | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 3.1: Qualify your own product | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 3.2: The seven rules of IVD classification | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 3.3: Milestone planning | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 3.4: GAP analysis of the technical documentation | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 4.1: Qualification and differentiation of combination products | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 4.2: Classification of combination products | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 4.3: Develop project plan | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Sprint 4.4: Assessing conformity and how to avoid typical errors | In vitro diagnostic medical devices | Not available in current plan.. | Book a free demo | |
| Your mission | The intended purpose | Not available in current plan.. | Book a free demo | |
| Preparation | The intended purpose | Not available in current plan.. | Book a free demo | |
| Fundamental principles | The intended purpose | Not available in current plan.. | Book a free demo | |
| Regulatory requirements (part 1) | The intended purpose | Not available in current plan.. | Book a free demo | |
| Checking intended purposes (part 1) | The intended purpose | Not available in current plan.. | Book a free demo | |
| Working with templates | The intended purpose | Not available in current plan.. | Book a free demo | |
| Intended use | The intended purpose | Not available in current plan.. | Book a free demo | |
| IEC 62366-1 and context of use | The intended purpose | Not available in current plan.. | Book a free demo | |
| Checking an intended purpose (part 2) | The intended purpose | Not available in current plan.. | Book a free demo | |
| Intended purpose for a product that is not your own | The intended purpose | Not available in current plan.. | Book a free demo | |
| Requirements of ISO 14971 | The intended purpose | Not available in current plan.. | Book a free demo | |
| Intended purpose of your own product | The intended purpose | Not available in current plan.. | Book a free demo | |
| Conflict prevention and resolution | The intended purpose | Not available in current plan.. | Book a free demo | |
| Sprint 1.1: Welcome & Introduction | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 1.2: Regulatory Basics | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 1.3: Overview of QM requirements | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 2.1: The first structure | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 2.2: MDR Annex I | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 2.3: Relevant SOPs | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 3.1: Structure for international approvals | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 3.2: Annex II | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 3.3: SOP of the Johner Institute | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 4.1: Product-specific structure | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 4.2: MDR Annex III | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 4.3: Medical device file | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 5.1: Sorting the documents | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 5.2: Standards | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 5.3: TD Review | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 6.1: Checklists | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 6.2: Meta requirements | Technical documentation | Not available in current plan.. | Book a free demo | |
| Sprint 6.3: Update | Technical documentation | Not available in current plan.. | Book a free demo | |
| ISO 10993-1 and Biocompatibility - Material Certificates Are Not Enough! | Biocompatability | Not available in current plan.. | Book a free demo | |
| Cytotoxicity Testing According to EN ISO 10993-5: Avoiding Pitfalls When Choosing a Laboratory | Biocompatability | Not available in current plan.. | Book a free demo | |
| No animal testing to prove biocompatibility | Biocompatability | Not available in current plan.. | Book a free demo | |
| EN ISO 18562: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications | Biocompatability | Not available in current plan.. | Book a free demo | |
| ISO 17664-1 – Information on Processing of Medical Devices | Biocompatability | Not available in current plan.. | Book a free demo | |
| Sprint 1: Introduction & Basics for Successful FDA Approval | FDA-approval | Not available in current plan.. | Book a free demo | |
| Sprint 2: The different FDA approval processes | FDA-approval | Not available in current plan.. | Book a free demo | |
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