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ISO 14155:2020 Medical Device Standard

ISO 14155:2020 Medical Device Standard Certification Training

 
Rated 4.1 / 5
(21 reviews)

Program/Course ID:CP008a
Enrollment Period:12 months.
Average Learning Time:~45 minutes.
Additional Resources:Supplemental materials & activities.
Credit Hours:2 credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Catalog:Clinical Trials Management and Monitoring.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote or invoice.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with QR validation code.
  Price: $199.00 USD  

Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.

Training Program: ISO 14155:2020 Medical Device Standard
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment.
Description:
Biopharma Institute Reviews

Master the global gold standard for medical device clinical trials with this detailed course on ISO 14155:2020. Learn how to integrate Good Clinical Practice (GCP) into every stage of a medical device trial to ensure reliability and regulatory compliance.

  • Overview of the ISO 14155:2020 standard
  • Planning and conducting device clinical investigations
  • Responsibilities of sponsors and investigators
  • Study close-out, suspension, and termination procedures

Essential for organizations conducting device trials seeking international recognition and compliance with leading GCP standards.

Take the next step in your professional growth and earn an industry-recognized certification from Biopharma Institute -designed for professionals who want to excel in ensuring the safety and effectiveness of medicinal products.

These programs not only give you up-to-date regulatory and compliance insights but also deliver practical skills that employers value. Whether you're enhancing your current role or preparing for a new opportunity, Biopharma Institute certifications are designed to set you apart in the competitive and highly regulated pharmaceutical industry.


Outline:


  • 1. Overview of the ISO Standard (Sections 1, 2, and 3)
  • a. International Organization for Standardization Background & What are ISO Standards
  • b. ISO 14155:2020 Background
  • c. ISO 14155:2020 - Table of Contents
  • d. Know the Standard Activity and Answer
  • e. ISO 14155:2020 and GCP
  • f. When is ISO 14155:2020 Enforceable?
  • g. CIP vs. Protocol
  • h. Important Terminology - Normative vs. Informative
  • i. General Changes to ISO 14155:2020

  • 2. Clinical Investigation Planning (Section 6)
  • a. Clinical Investigation Plan (CIP)
  • b. Annex A
  • c. Clinical Procedure Risks and Their Disclosure
  • d. ISO 14155:2020: Risk Assessment (Annex H)
  • e. Risk Management for Sponsors
  • f. Risk Management and the CIP Knowledge Check
  • g. Investigator's Brochure (links to Annex B)
  • h. Monitoring Plan Overview
  • i. Monitoring Plan Elements
  • j. Case Report Forms (CRFs) (links to Annex C)
  • k. Investigation Site Selection
  • l. Know the Standard Activity and Answer

  • 3. Responsibilities of the Sponsor (Section 9)
  • a. Site Selection and Training Requirements
  • b. Monitoring: Clinical Quality Management
  • c. Investigation Site Initiation (7.2)
  • d. Monitoring: CIP and Investigators
  • e. CRO, Vendor, Site Oversight
  • f. Routine Monitoring Visits
  • g. Monitoring: Documentation (Informed Consent, eCRF, AE or ADE)
  • h. Preparation of Documents
  • i. Certified Copies and Validated Systems
  • j. Know the Standard Activity and Answer

  • 4. Responsibilities of the Investigator (Section 5 and 10)
  • a. Responsibilities of the Investigator Intro
  • b. Investigator Qualifications
  • c. Investigation Site (7.2, 9.2.1, 7.6, &10.3)
  • d. Communication with Ethics Committee (5.6 and 10.4)
  • e. Ethics Requirements
  • f. Informed Consent (10.5 & 5.8)
  • g. Informed Consent Requirements
  • h. Responsibilities of the Investigator
  • i. Investigator Compliance with the CIP
  • j. Know the Standard Activity and Answer

  • 5. Clinical Investigation Conduct and Safety (Section 7)
  • a. Section 7: Clinical Investigation Conduct
  • b. Know the Standard Activity and Answer
  • c. Safety Requirements
  • d. ISO 14155:2020: Adverse Events & Device Deficiencies (7.4)
  • e. Adverse Events and Device Deficiencies Definitions
  • f. ISO 14155:2020: Device Deficiencies
  • g. Risk Assessment (Section 7.4.4)
  • h. Adverse Event Characterization (AE, SAE, ADE, SADE, USADE, DD)
  • i. Annex F
  • j. ISO 14155:2020 Annex E Essential Documents

  • 6. Suspension, Termination, and Close-out of Clinical Investigation (Section 8)
  • a. Routine Closeout
  • b. Termination/Suspension/Close-out, Including Report, Risk Assessment & Conclusions
  • c. Document Retention (links to Annex E)
  • d. Audits (Annex J)
  • e. Clinical Investigation Report (Annex D)

  • 7. Scenario

  • 8. 10 Question Post Assessment

Objectives:


  • Describe the ISO 14155:2020 standard requirements for Medical Device GCP.
  • Recognize how the ISO 14155:2020 standard applies to activities related to site monitoring and investigator responsibilities.
  • Apply the ISO 14155:2020 standard to study activities.

Audience:
All clinical research personnel

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Benefits of Training with Biopharma Institute

Immediate Course Access: Login details, instructions, and payment confirmation are emailed immediately upon online enrollment.
Self-Paced eLearning: Enjoy 24/7 access to all course materials and assessments for 12 months.
Open Enrollment: No prerequisites or prior work experience required to start.
Expert-Developed Content: Courses are designed by subject matter experts (SMEs) in their respective fields.
Up-to-Date & Validated: Training is regularly updated to meet current regulations and is third-party validated or accredited.
Optimized for Learning: Courses feature voiceovers, intuitive navigation, reading materials, case studies, progress checks, and animations to boost knowledge retention.
Secure Access: Encrypted connections, firewalls, and daily malware scans ensure security and system performance.
Flexible Assessments: Multiple-choice exams can be retaken until a passing score is achieved.
Instant Certificates: Certificates are issued instantly in secure PDF format with watermark, unique validation code, and QR code for verification.
Training Verification: Certificates can be verified online using a QR code or unique ID. Digital badges are included with professional certifications.
Manager Access: A secure portal allows managers to view and download enrollment reports, training records, account balances, and more.
SCORM-Compliant: Courses can be integrated directly into most corporate Learning Management Systems (LMS).
Purchase Orders: We accept POs from all companies. Request an invoice to start the procurement process.
Employer Reimbursement: Some employers may cover training costs -check your company's reimbursement policy.
Financial Assistance: Payment plans are available for eligible learners, or purchase courses individually as needed.
Career Advancement: Professional certifications highlight dedication to career growth, enhance resumes, provide interview talking points, and equip learners with practical job skills.


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