ISO 14971:2019 - Certified Lead Auditor

Certification Overview

ISO 14971:2019 - Certified Lead Auditor

Exam Code: ISO-14971-LA

ISO 14971:2019 outlines a framework for applying risk management to medical devices. It emphasizes identifying, evaluating, and controlling risks throughout a device's lifecycle, ensuring patient safety. The standard guides manufacturers in making informed decisions, balancing benefits and risks, and complying with regulatory requirements to enhance healthcare outcomes.

The ISO 14971:2019 - Certified Lead Auditor course is typically designed for professionals involved in the medical device industry, particularly those responsible for quality management systems and risk management. 

Exam Information

The exam comprises of 40 Multiple Choice Questions out of which the candidate needs to score 70% (28 out of 40 correct) to pass the exam.

The total duration of the exam is 1 hour (60 Minutes).

  • The exam is delivered through ProctorU in a proctored mode. With a webcam and a reliable internet connection, exam can be taken anytime and anywhere.
  • Upon purchasing the Premium Package or an Exam Voucher Code, a voucher code with two attempts will be assigned to your login profile.
  • The Exam Voucher included in the Premium Package or purchased separately is valid for two (2) attempts. If you are unable to pass the exam within these two attempts, you can purchase a new voucher code, which will grant you an additional two attempts.

The ISO 14971:2019 - Certified Lead Auditor is valid for life.

Displaying your certificate

  • Remember, when labeling a product or system as certified to an ISO standard:
  • Don't say: "ISO certified" or "ISO certification"
  • DO say: "ISO 9001:2008 certified" or "ISO 9001:2008 certification" (for example).

N/A

The Certificaiton has no specific prerequisites.

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Course Outline

Module Information - 1

  • Introduction to ISO 14971:2019
  • Understanding the Requirements of ISO 14971:2019
  • Risk Management Process
  • Auditing Techniques

Module Information - 2

  • Lead Auditor Responsibilities
  • Practical Auditing Exercises
  • Regulatory Requirements and ISO 14971:2019
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Target Audience

  • Quality Assurance Professionals: Individuals working in quality assurance within the medical device industry who need to understand and implement ISO 14971:2019 requirements.
  • Regulatory Affairs Professionals: Professionals responsible for ensuring that medical devices comply with regulations and standards.
  • Internal Auditors: Individuals who conduct internal audits within an organization and need to understand ISO 14971:2019 for auditing purposes.
  • Consultants: Consultants providing services to medical device companies and advising on compliance with ISO 14971:2019.
  • Risk Management Professionals: Individuals who are involved in managing risks associated with medical devices and need to align their processes with ISO 14971:2019.
  • Project Managers: Managers overseeing medical device development projects who need to ensure that risk management is integrated into the project lifecycle.
  • Medical Device Designers and Engineers: Professionals involved in the design and development of medical devices who need to understand the risk management process as per ISO 14971:2019.
  • Compliance Officers: Individuals responsible for ensuring that the company adheres to regulatory and standards requirements, including ISO 14971:2019.

Registration Process for E-Course or E-Book and Exam

Exam
Voucher

  • Validity: 240 Days
  • Price: 190 USD
  • Please Read Carefully:

    1) The Exam Voucher is valid for two (2) attempts.

    2) You will receive your voucher code within 24 business hours.

    3) You can schedule your exam through ProctorU.

Exam Registration

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