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ISO 14155:2020 Medical Device Standard

ISO 14155:2020 Medical Device Standard Certification Training

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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.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.
  Price: $199.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.

Training Program: ISO 14155:2020 Medical Device Standard
Training Provided By: Biopharma Institute

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

Biopharma Institute ReviewsDesigning and conducting a clinical trial should be done with Good Clinical Practice (GCP) and quality in mind to ensure the reliability of trial results as well as to follow requirements of regulatory authorities. Organizations usually understand the necessity of following ICH E6(R2) to ensure GCP; however, there is frequently a gap in training internal teams, contractors, CROs, and sites on ISO 14155:2020 GCP for medical devices. Following the standard is a key part of building globally recognized GCP into the full life cycle of the medical device clinical trial and can complement the current GCP training.

This course covers an overview of the ISO 14155:2020 standard for medical device GCP. Use with a copy of your organization's standard or purchase a copy from

Content includes an Overview of the Standard, Clinical Investigation Planning, Sponsor Responsibilities, Responsibilities of the Investigator, Clinical Investigation Conduct, and Suspension, Termination, and Close-out of Clinical Investigation.

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.


  • 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


  • 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.

All clinical research personnel

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Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

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Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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