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