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Clinical Evaluation Report: Review for Regulatory Professionals

Clinical Evaluation Report: Review for Regulatory Professionals

The European Medical Device New Regulation 2017/745

The European Medical Device New Regulation 2017/745

ISO 14155:2020 – A Summary Review

ISO 14155:2020 – A Summary Review

Applying GDPR to Medical Devices Clinical Investigations

Applying GDPR to Medical Devices Clinical Investigations

EU-MDR 2017/745 Review for Clinical Professionals

EU-MDR 2017/745 Review for Clinical Professionals

Clinical Evaluation for Market Approval

Clinical Evaluation for Market Approval

Data from Prospective Clinical Investigation for CE-Mark: Review for Regulatory Professionals

Data from Prospective Clinical Investigation for CE-Mark: Review for Regulatory Professionals

Clinical Evaluation Report: Review for Regulatory Professionals

Clinical Evaluation Report: Review for Regulatory Professionals

Conducting Medical Device Clinical Investigations in Switzerland

Conducting Medical Device Clinical Investigations in Switzerland

Pre-Market Approval for Medical Device in China

Pre-Market Approval for Medical Device in China

ISO 14155_课程1_范围

ISO 14155_课程1_范围

Effective Time Management

Effective Time Management

Effective Time Management

Effective Time Management

MEDDEV 2.7.1 rev 4 versus rev 3 - A Gap Analysis

MEDDEV 2.7.1 rev 4 versus rev 3 - A Gap Analysis

IVD Australia: Making Applications for Inclusion on the ARTG

IVD Australia: Making Applications for Inclusion on the ARTG

IVD Australia: Basics for including an IVD on the ARTG

IVD Australia: Basics for including an IVD on the ARTG

internal auditor

internal auditor

What’s changing in Rev 4 of MEDDEV 2.7.1

What’s changing in Rev 4 of MEDDEV 2.7.1

Clinical Evaluation report of Existing data for CE-mark: review for regulatory professionals

Clinical Evaluation report of Existing data for CE-mark: review for regulatory professionals

The ASEAN Common Submission Dossier Template (CSDT) and Its Contents

The ASEAN Common Submission Dossier Template (CSDT) and Its Contents

The Australian Regulatory System for Medical Devices

The Australian Regulatory System for Medical Devices

ISO 13485 - Medical Devices Quality Management Systems Requirements for Regulatory Purposes

ISO 13485 - Medical Devices Quality Management Systems Requirements for Regulatory Purposes

singapore

singapore

Applied Project Management: Project Leadership

Applied Project Management: Project Leadership

Applied Project Management: Project Planning

Applied Project Management: Project Planning

Applied Project Management: Project Organization

Applied Project Management: Project Organization

Applied Project Management: Project Environment

Applied Project Management: Project Environment

Applied Project Management: Risks and Opportunities

Applied Project Management: Risks and Opportunities

Applied Project Management: Project Realization

Applied Project Management: Project Realization

Applied Project Management: Visualizing

Applied Project Management: Visualizing

Applied Project Management: Objectives and Arena

Applied Project Management: Objectives and Arena

Applied Project Management: Project Stakeholders

Applied Project Management: Project Stakeholders

Applied Project Management: Project!

Applied Project Management: Project!

Powerful Presentation Skills

Powerful Presentation Skills

The Main Concepts for Safe and Performing Devices

The Main Concepts for Safe and Performing Devices

Creating Value in Healthcare

Creating Value in Healthcare

Clinical Evaluation of Medical Devices: an Introduction

Clinical Evaluation of Medical Devices: an Introduction

Introduction to Digital Governance: A Four-Step Approach

Introduction to Digital Governance: A Four-Step Approach

Post Market Surveillance: an Introduction

Post Market Surveillance: an Introduction

Developing Markets for Medical Technologies: How to Drive Adoption

Developing Markets for Medical Technologies: How to Drive Adoption

The Lifecycle of Medical Devices from Idea to Market

The Lifecycle of Medical Devices from Idea to Market

Intellectual Property Concepts for Medical Devices

Intellectual Property Concepts for Medical Devices

Business Plan Essentials for Medical Products

Business Plan Essentials for Medical Products

What is considered a Medical Device?

What is considered a Medical Device?

Steps to CE Mark

Steps to CE Mark

Introduction to the EU Regulatory System

Introduction to the EU Regulatory System

German Healthcare System

German Healthcare System

UK Healthcare System

UK Healthcare System

Health Economic Evaluation of Medical Technologies

Health Economic Evaluation of Medical Technologies

Reimbursement Strategy for Medical Devices in the US

Reimbursement Strategy for Medical Devices in the US

Developing an EU Reimbursement Strategy for a Medical Device

Developing an EU Reimbursement Strategy for a Medical Device

Introduction to European Funding and Reimbursement Systems

Introduction to European Funding and Reimbursement Systems

french healthcare

french healthcare

The Basics of US Private Payer Reimbursement for Medical Devices

The Basics of US Private Payer Reimbursement for Medical Devices

Italian Healthcare System

Italian Healthcare System

Introduction to Combination Products in the USA

Introduction to Combination Products in the USA

Introduction to Drug-Device Combination Regulations in Europe

Introduction to Drug-Device Combination Regulations in Europe

Clinical Evaluation for EU Market Approval: Process and Regulatory background

Clinical Evaluation for EU Market Approval: Process and Regulatory background

Clinical Protocol Writing Process and Ensuring Compliance

Clinical Protocol Writing Process and Ensuring Compliance

Clinical Data for Reimbursement

Clinical Data for Reimbursement

CPM: Close Out and Clinical Report of a Medical Device Clinical Trial

CPM: Close Out and Clinical Report of a Medical Device Clinical Trial

Clinical Evaluation for EU Market Approval: Literature Review

Clinical Evaluation for EU Market Approval: Literature Review

Data Safety & Monitoring Board (DSMB) Establishment

Data Safety & Monitoring Board (DSMB) Establishment

CPM: Objectives and Setup of a Medical Device Clinical Trial

CPM: Objectives and Setup of a Medical Device Clinical Trial

CPM: The Clinical Trial master plan for Medical Devices

CPM: The Clinical Trial master plan for Medical Devices

Clinical Evaluation for EU Market Approval: Step by Step Primer

Clinical Evaluation for EU Market Approval: Step by Step Primer

CPM: Medical Device Clinical Trial Team Resources

CPM: Medical Device Clinical Trial Team Resources

Designing a Strategic Medical Device Clinical Investigation Plan/Protocol

Designing a Strategic Medical Device Clinical Investigation Plan/Protocol

CPM: Managing Ongoing Medical Device Clinical Trials

CPM: Managing Ongoing Medical Device Clinical Trials

CPM: Tracking and Reporting Rules for Medical Device Clinical Trials

CPM: Tracking and Reporting Rules for Medical Device Clinical Trials

CPM: Medical Device Clinical Trials - Budget and Timelines Planning

CPM: Medical Device Clinical Trials - Budget and Timelines Planning

Clinical Events Committee (CEC) Establishment

Clinical Events Committee (CEC) Establishment

CPM: Effective Communication Methods during Medical Device Clinical Trials

CPM: Effective Communication Methods during Medical Device Clinical Trials

Format and Structure of a Medical Device Clinical Investigation Plan/Protocol

Format and Structure of a Medical Device Clinical Investigation Plan/Protocol

CPM: Compliance Management during Medical Device Clinical Trials

CPM: Compliance Management during Medical Device Clinical Trials

CPM: Project Guidelines for Medical Device Clinical Trials

CPM: Project Guidelines for Medical Device Clinical Trials

Medical Device Clinical Investigation in Germany – Requirements of the Radiation Ordinances

Medical Device Clinical Investigation in Germany – Requirements of the Radiation Ordinances

Conducting Medical Device Clinical Investigations in Singapore

Conducting Medical Device Clinical Investigations in Singapore

BIMO: IDE Investigator Obligations

BIMO: IDE Investigator Obligations

Clinical Audits: Sponsor/Third Party Audits of Clinical Investigation sites

Clinical Audits: Sponsor/Third Party Audits of Clinical Investigation sites

Conducting Medical Device Clinical Investigations in Switzerland

Conducting Medical Device Clinical Investigations in Switzerland

Conducting studies using Electronic Data Capture

Conducting studies using Electronic Data Capture

Centralized vs. Onsite Monitoring Applying FDA’s Risk-Based Approach

Centralized vs. Onsite Monitoring Applying FDA’s Risk-Based Approach

Negotiating EU Clinical Investigation Agreements

Negotiating EU Clinical Investigation Agreements

Clinical Audits: Auditing the Clinical Research Organisation and the Sponsor

Clinical Audits: Auditing the Clinical Research Organisation and the Sponsor

BIMO: IDE Sponsor Obligations

BIMO: IDE Sponsor Obligations

Understanding EU Clinical Investigation Agreements

Understanding EU Clinical Investigation Agreements

BIMO: US FDA BIMO Compliance Program

BIMO: US FDA BIMO Compliance Program

Conducting Medical Device Clinical Investigations in Romania

Conducting Medical Device Clinical Investigations in Romania

Clinical Audits: Fundamentals of Auditing Medical Device Clinical Investigations

Clinical Audits: Fundamentals of Auditing Medical Device Clinical Investigations

Conducting Medical Device Clinical Investigations in Germany

Conducting Medical Device Clinical Investigations in Germany

Overview of Data Management Plan and Query Process

Overview of Data Management Plan and Query Process

Source Document Verification

Source Document Verification

Initiation Visit

Initiation Visit

Device Accountability

Device Accountability

The Close Down Visit

The Close Down Visit

Good Documentation Practices for Clinical Study Files

Good Documentation Practices for Clinical Study Files

Visit Report Writing

Visit Report Writing

Ethics Committee(EC) / Institutional Review Board Requirements

Ethics Committee(EC) / Institutional Review Board Requirements

The Periodic Monitoring Visit

The Periodic Monitoring Visit

The Informed Consent Process

The Informed Consent Process

Deviations and Non-Compliance Handling

Deviations and Non-Compliance Handling

Adverse Event Processes

Adverse Event Processes

The Case Report Form Process

The Case Report Form Process

Selecting Investigation Sites

Selecting Investigation Sites

The Clinical Investigation Plan

The Clinical Investigation Plan

Introduction to Medical Device and Clinical Investigation Planning

Introduction to Medical Device and Clinical Investigation Planning

Introduction to Good Clinical Practice

Introduction to Good Clinical Practice

History of Good Clinical Practice (GCP)

History of Good Clinical Practice (GCP)

GCP for Investigators: Clinical Investigation Close out or Termination

GCP for Investigators: Clinical Investigation Close out or Termination

GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations

GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations

GCP for Investigators: Initiation of a Medical Device Clinical Investigation

GCP for Investigators: Initiation of a Medical Device Clinical Investigation

GCP for Investigators: How to Qualify for Medical Device Clinical Investigations

GCP for Investigators: How to Qualify for Medical Device Clinical Investigations

GCP for Investigators: Clinical Investigation Conduct and Reporting

GCP for Investigators: Clinical Investigation Conduct and Reporting

GCP for Investigators: Introduction to Medical Devices

GCP for Investigators: Introduction to Medical Devices

European Safety Reporting Requirements during Pre-Market clinical Investigations

European Safety Reporting Requirements during Pre-Market clinical Investigations

US Safety Reporting Requirements during Pre-Market Clinical Trials

US Safety Reporting Requirements during Pre-Market Clinical Trials

Medical Device GCP: A Practical Summary

Medical Device GCP: A Practical Summary

The European Medical Device New Regulation

The European Medical Device New Regulation

Managing Data Release Consent During Post Market Studies

Managing Data Release Consent During Post Market Studies

IRB Review of Medical Devices

IRB Review of Medical Devices

Importance of Clinical Investigator´s Brochure (IB)

Importance of Clinical Investigator´s Brochure (IB)

Directive 93/42/EEC and update 2007/47/EC: A review for clinical professionals (rev 1.2)

Directive 93/42/EEC and update 2007/47/EC: A review for clinical professionals (rev 1.2)

Accelerating Successful Patient Recruitment

Accelerating Successful Patient Recruitment

Good Laboratory Practices & Biological Evaluation for Medical Devices

Good Laboratory Practices & Biological Evaluation for Medical Devices

Biocompatibility of Medical Devices

Biocompatibility of Medical Devices

Standalone Software Under the Medical Devices Directives

Standalone Software Under the Medical Devices Directives

Imaging Modalities Used in Pre-clinical Research

Imaging Modalities Used in Pre-clinical Research

Validating Software used in Company Processes

Validating Software used in Company Processes

Understanding Software Validation

Understanding Software Validation

IEC 60601-1 Ed 3.1 - Medical Electrical Systems and Protection Against Mechanical Hazards

IEC 60601-1 Ed 3.1 - Medical Electrical Systems and Protection Against Mechanical Hazards

IEC 60601-1 Ed 3.1 - Protection Against Thermal and Other Hazards and Components

IEC 60601-1 Ed 3.1 - Protection Against Thermal and Other Hazards and Components

IEC 60601-1 Ed 3.1 - Background and Introduction

IEC 60601-1 Ed 3.1 - Background and Introduction

IEC 60601-1 Ed 3.1 - Risk Management and General Requirements

IEC 60601-1 Ed 3.1 - Risk Management and General Requirements

IEC 60601-1 Ed 3.1 - Protection Against Electrical Shock, and verifying Electrical Insulation

IEC 60601-1 Ed 3.1 - Protection Against Electrical Shock, and verifying Electrical Insulation

Validation of Ethylene Oxide Sterilization of Medical Device

Validation of Ethylene Oxide Sterilization of Medical Device

Biological Evaluation of Medical Devices: A Risk-Based Approach

Biological Evaluation of Medical Devices: A Risk-Based Approach

Introduction to Process Validation

Introduction to Process Validation

IVD Australia: Fees for including an IVD device on the TGA or ARTG

IVD Australia: Fees for including an IVD device on the TGA or ARTG

IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD devices

IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD devices

IVD Australia: Making application for inclusion on the ARTG

IVD Australia: Making application for inclusion on the ARTG

IVD Australia: The use of GMDN codes for IVDs in Australia

IVD Australia: The use of GMDN codes for IVDs in Australia

IVD Australia: Basics for including an IVD on the ARTG

IVD Australia: Basics for including an IVD on the ARTG

Data from prospective clinical investigation for CE-mark: review for regulatory professionals

Data from prospective clinical investigation for CE-mark: review for regulatory professionals

Clinical Evaluation report of Existing data for CE-mark: review for regulatory professionals

Clinical Evaluation report of Existing data for CE-mark: review for regulatory professionals

Implications of EN ISO 14971:2012

Implications of EN ISO 14971:2012

Integrating Risk Management into Your Quality Management System

Integrating Risk Management into Your Quality Management System

Preparing Risk Management File & Which Techniques Apply

Preparing Risk Management File & Which Techniques Apply

ISO 14971: 2007 Review

ISO 14971: 2007 Review

RoHS Directive 2011/65/EU & WEEE Directive 2012/19/EU

RoHS Directive 2011/65/EU & WEEE Directive 2012/19/EU

US FDA Investigational Device Exemption (IDE) Overview

US FDA Investigational Device Exemption (IDE) Overview

US FDA 510(k) Notification Process

US FDA 510(k) Notification Process

Good Documentation & Writing Practices for Regulatory Submissions

Good Documentation & Writing Practices for Regulatory Submissions

The Draft European IVD Regulation

The Draft European IVD Regulation

Pathways to CE Marking under the In Vitro Diagnostics Directive

Pathways to CE Marking under the In Vitro Diagnostics Directive

GHTF/IMDRF: Summary Technical Documentation (STED) and Its Contents

GHTF/IMDRF: Summary Technical Documentation (STED) and Its Contents

GHTF/IMDRF – Essential Principles of Safety and Performance for Medical Devices

GHTF/IMDRF – Essential Principles of Safety and Performance for Medical Devices

GHTF/IMDRF – International Implementation

GHTF/IMDRF – International Implementation

GHTF/IMDRF – Supporting Documents

GHTF/IMDRF – Supporting Documents

GHTF/IMDRF – The Post-Market Model

GHTF/IMDRF – The Post-Market Model

GHTF/IMDRF: The Pre-Market Model

GHTF/IMDRF: The Pre-Market Model

Introduction to the GHTF or IMDRF

Introduction to the GHTF or IMDRF

Labeling Requirements for Medical Devices in the US

Labeling Requirements for Medical Devices in the US

Electronic Instructions for Use for Medical Devices in the European Union

Electronic Instructions for Use for Medical Devices in the European Union

Labeling Requirements for Medical Devices in Europe

Labeling Requirements for Medical Devices in Europe

Strategic Approach to Bringing Medical Devices to the Indonesian Market

Strategic Approach to Bringing Medical Devices to the Indonesian Market

Registration Process for Medical Devices in Brazil

Registration Process for Medical Devices in Brazil

Medical Device Pre-Market Approval Process in Korea

Medical Device Pre-Market Approval Process in Korea

The European Union Regulatory System for Medical Devices

The European Union Regulatory System for Medical Devices

The Japanese Regulatory System for Medical Devices

The Japanese Regulatory System for Medical Devices

The Hong Kong Regulatory System for Medical Devices

The Hong Kong Regulatory System for Medical Devices

The Australian Regulatory System for In-Vitro Diagnostic (IVD) Devices

The Australian Regulatory System for In-Vitro Diagnostic (IVD) Devices

Introduction to the US FDA

Introduction to the US FDA

Regulatory Framework for In Vitro Medical Devices in the US

Regulatory Framework for In Vitro Medical Devices in the US

Role of RA Specialist in the Design Process

Role of RA Specialist in the Design Process

Demarcation of Medical Devices to other Products

Demarcation of Medical Devices to other Products

Active Medical Devices in Europe: Particular Requirements

Active Medical Devices in Europe: Particular Requirements

Complaint Handling and Reporting Process for Medical Devices

Complaint Handling and Reporting Process for Medical Devices

How to Navigate Through the ISO 13485 Certification Process

How to Navigate Through the ISO 13485 Certification Process

ISO 13485: Foundation and Basic Principles

ISO 13485: Foundation and Basic Principles

Project Management of Medical Device Development

Project Management of Medical Device Development

Preparing Successfully for a US FDA Medical Device Inspection

Preparing Successfully for a US FDA Medical Device Inspection

Internal Auditor Training for Medical Device Manufacturers

Internal Auditor Training for Medical Device Manufacturers

Importance of Technical Standards in the Medical Device Sector

Importance of Technical Standards in the Medical Device Sector

overview of US FDA 1

overview of US FDA 1

Supplier Qualification

Supplier Qualification

World Medical Device Organization

World Medical Device Organization