About ISO 13485:2016

Join our course to delve into ISO 13485, the gold standard for quality management systems in the medical device industry. Gain insights into how this standard ensures safety, efficacy, and regulatory compliance, empowering you to excel in the competitive healthcare market. Let's unlock the secrets together!

Course Curriculum

5 Chapters · 20 Lessons

  1. 1

    Introduction to ISO 13485

    1. (Included in full purchase)

      Understanding ISO 13485

    2. (Included in full purchase)

      Key Components of the Standard

    3. (Included in full purchase)

      Briefing Document: ISO 13485 - Quality Management Systems for Medical Devices

    4. (Included in full purchase)

      ISO 13485:2016 Study Guide

  2. 2

    Implementing a Quality Management System

    1. (Included in full purchase)

      Establishing a QMS Framework

    2. (Included in full purchase)

      Document Control and Record Keeping

    3. (Included in full purchase)

      Briefing Doc: Essential Documentation Practices for ISO 13485:2016

    4. (Included in full purchase)

      ISO 13485:2016 Quality Management System for Medical Devices

  3. 3

    Risk Management and Regulatory Compliance

    1. (Included in full purchase)

      Risk Management Principles

    2. (Included in full purchase)

      Navigating Regulatory Requirements

    3. (Included in full purchase)

      Briefing Document: ISO 13485:2016 and Risk Management in Medical Device Development

    4. (Included in full purchase)

      ISO 13485:2016 Study Guide

  4. 4

    Continuous Improvement and Auditing

    1. (Included in full purchase)

      Establishing a Culture of Continuous Improvement

    2. (Included in full purchase)

      Conducting Internal Audits

    3. (Included in full purchase)

      Briefing Doc: Continuous Improvement and Internal Audits for Medical Device Compliance

    4. (Included in full purchase)

      ISO 13485:2016 and Continuous Improvement in Medical Device Development

  5. 5

    Practical Applications and Case Studies

    1. (Included in full purchase)

      Real-World Applications of ISO 13485

    2. (Included in full purchase)

      Preparing for Certification

    3. (Included in full purchase)

      Briefing Document: Effective ISO 13485:2016 Implementation and Certification

    4. (Included in full purchase)

      ISO 13485:2016 Implementation and Certification Study Guide

Ready to Elevate Your Medical Device Quality Management?

Take the next step towards excellence in quality management systems. Enroll now and unlock the power of ISO 13485 for your success.

Contact Us for Access (opens email in new window)