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Results for tag: "ISO 14971"

Risk Management and Internal Auditing: Effective quality audits with inclusion of ISO 14971:2007 - Product Thumbnail Image

Risk Management and Internal Auditing: Effective quality audits with inclusion of ISO 14971:2007

  • Training
  • 60 Minutes
  • Global
International GMP's for Medical Devices: Quality System requirements for USA, Europe, Canada and Japan - Product Thumbnail Image

International GMP's for Medical Devices: Quality System requirements for USA, Europe, Canada and Japan

  • Training
  • Canada, Japan, United States, ... Canada, Japan, United States, Europe, Global
Effectively application of FMEA as a Risk Management Tool and meet ISO 13485:2003 Risk Management (ISO 14971) Requirements - Product Thumbnail Image

Effectively application of FMEA as a Risk Management Tool and meet ISO 13485:2003 Risk Management (ISO 14971) Requirements

  • Training
  • 60 Minutes
  • Global
Integrating Clinical Evaluation and Risk Management - Product Thumbnail Image

Integrating Clinical Evaluation and Risk Management

  • Training
  • 90 Minutes
  • Global
Medical Device Cybersecurity Following New FDA Guidance - Product Thumbnail Image

Medical Device Cybersecurity Following New FDA Guidance

  • Training
  • 60 Minutes
  • Global
Post-market Surveillance - Clinical Evaluation and Risk Management - Product Thumbnail Image

Post-market Surveillance - Clinical Evaluation and Risk Management

  • Training
  • 90 Minutes
  • Global
The New US FDA 21 CFR 820, Quality Management System Regulation (QMSR), Medical Device CGMPs - Product Thumbnail Image

The New US FDA 21 CFR 820, Quality Management System Regulation (QMSR), Medical Device CGMPs

  • Training
  • 90 Minutes
  • United States
Risk Management for Medical Devices per ISO 14971 2019 - Product Thumbnail Image

Risk Management for Medical Devices per ISO 14971 2019

  • Training
  • 60 Minutes
  • Global
Integrating ISO 14971 Risk Analysis into the Product Development Process - Product Thumbnail Image

Integrating ISO 14971 Risk Analysis into the Product Development Process

  • Training
  • 90 Minutes
  • Global
ISO 14971:2007 -- The Newly Revised Risk Management Standard for Medical Products - Product Thumbnail Image

ISO 14971:2007 -- The Newly Revised Risk Management Standard for Medical Products

  • Training
  • 60 Minutes
  • Global
ISO 14971: Understanding and Applying Risk Management - Product Thumbnail Image

ISO 14971: Understanding and Applying Risk Management

  • Training
  • 120 Minutes
  • Global
3-hr Virtual Seminar- Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada - Product Thumbnail Image

3-hr Virtual Seminar- Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada

  • Training
  • 3 Hours
  • Europe, United States, ... Europe, United States, Canada
10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance - Product Thumbnail Image

10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance

  • Training
  • 60 Minutes
  • United States
Risk Management Under ISO 14971 - Product Thumbnail Image

Risk Management Under ISO 14971

  • Training
  • 60 Minutes
  • Global
Overview of the Medical Device Risk Management Standard-ISO 14971 - Product Thumbnail Image

Overview of the Medical Device Risk Management Standard-ISO 14971

  • Training
  • 90 Minutes
  • Global
Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries - Product Thumbnail Image

Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries

  • Training
  • 60 Minutes
  • Global
Conformance of Design History Files for Mature Medical Devices - Product Thumbnail Image

Conformance of Design History Files for Mature Medical Devices

  • Training
  • 60 Minutes
  • Global
Medical Device: Risk Assessment and Mitigation through FMEA - Product Thumbnail Image

Medical Device: Risk Assessment and Mitigation through FMEA

  • Training
  • 90 Minutes
  • Global
An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971 - Product Thumbnail Image

An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971

  • Training
  • 60 Minutes
  • Global
Post Market Surveillance for Medical Devices - Product Thumbnail Image

Post Market Surveillance for Medical Devices

  • Training
  • 90 Minutes
  • Global
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ISO 14971 is an international standard for risk management in the medical device industry. It provides a framework for manufacturers to identify, assess, and control risks associated with their products. The standard is designed to ensure that medical devices are safe and effective for their intended use. It is applicable to all stages of the product life cycle, from design and development to production and post-market surveillance. ISO 14971 is widely used by medical device manufacturers, regulatory authorities, and other stakeholders in the industry. It is an important tool for ensuring the safety and efficacy of medical devices, and is often used in conjunction with other standards such as ISO 13485 and IEC 60601. Some companies in the ISO 14971 market include Johnson & Johnson, Medtronic, Abbott, Becton Dickinson, and Stryker. Show Less Read more