Student Login |

Friday, June 18, 2021
Home » ISO 14971:2019 - The Scope of the Standard

ISO 14971:2019 - The Scope of the Standard (ELM-333)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: ISO 14971:2019 - The Scope of the Standard
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsRisk management for medical devices is an absolute requirement worldwide. The review of the Risk Management File is getting a critical and thorough assessment by regulatory bodies. Beyond that, good Risk Management just makes good business sense. Nobody wants their device to harm patients and there can be severe financial repercussions if devices do cause harm. ISO 14971:2019 is the latest version of the most generally accepted standard for medical device risk management. This program is tailored around that standard. In this course we will focus on the scope of the standard.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

ISO 14971:2019 - The Scope of the Standard course is included in the following Professional Certification Programs:

ISO 14971:2019 for Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more


Program Introduction
Learning Objectives
Who Will Benefit from This Training?
Materials Used
Program Overview
Course Introduction
Course Overview
Learning Objectives

Section 1: Scope
Always Managing Risk
An Holistic Approach

Section 2: Normative References
Normative References

Section 3: Terms and Definitions
Harm & Hazard
Hazardous Situation
Reasonably Foreseeable Misuse
Residual Risk, Risk and Risk Control
State of the Art
Use Error
Revisiting Section 1: Scope
Is / Is Not
Where it Fits
Expectations from 60601
Integration with Usability Engineering
Integration with Software Development

Section 4: General Requirements for Risk Management Systems
Section 4.1 Risk Management Process - Part 1
Section 4.1 Risk Management Process - Part 2
Section 4.2 Management Responsibility - Part 1
Section 4.2 Management Responsibility - Part 2
Section 4.3 Competence of Personnel - Part 1
Section 4.3 Competence of Personnel - Part 1


Final Assessment



Skill Level:

This training program has been developed to train employees with Intermediate Knowledge of 1SO 14971:2019 (Medical Devices).

Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

Information Request / Suggest a Course Form:

Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us with as much detail as possible about your training project):