Mastering ISO 14155 Clinical Investigations of Medical Devices for Regulatory Compliance and Market Access

You’re under pressure. Deadlines are tightening. A clinical investigation is stalled because your team lacks a unified understanding of ISO 14155. Regulators are scrutinizing your documentation. One misstep could mean rejection, delays, or worse-product recall risks.

You know the stakes. Medical device approval isn’t just about innovation. It’s about compliance, precision, and delivering evidence that meets global standards. Falling short on ISO 14155 can cost months and millions. But mastering it? That’s your competitive edge.

Mastering ISO 14155 Clinical Investigations of Medical Devices for Regulatory Compliance and Market Access is not another theoretical overview. It’s a complete, step-by-step mastery system designed for professionals who need to design, manage, and audit clinical investigations that pass regulatory scrutiny the first time.

This course delivers a clear path: from confusion and compliance gaps to confident, audit-ready documentation and successful market submissions. In as little as 21 days, you’ll build a fully aligned plan for your next clinical investigation-complete with risk assessments, protocol frameworks, and regulatory alignment strategies ready for submission.

Lidia M., a Clinical Affairs Manager at a leading EU MDR-registered diagnostics firm, used this program to restructure her team’s ISO 14155 audit preparation. Within 18 days, they passed a notified body review with zero non-conformities-a first in three years.

Here’s how this course is structured to help you get there.

Course Format & Delivery Details

Self-Paced Learning with Immediate Online Access

The entire course is self-paced, allowing you to progress on your schedule. Once enrolled, you gain instant access to all materials, with no fixed start dates or time commitments. You control when, where, and how quickly you learn.

Flexible and Mobile-Friendly Learning Experience

Access your training from any device-desktop, tablet, or smartphone. The interface is fully responsive and engineered for smooth navigation, whether you're in the office, at a site visit, or traveling internationally.

Real Results in Under 30 Days

Most professionals complete the core curriculum in 20 to 30 hours. You can implement key sections within the first week and apply immediate improvements to ongoing projects, audits, or submissions.

Lifetime Access with Ongoing Updates

Your enrollment includes lifetime access to all course materials. As regulatory standards evolve and global guidance is updated, your content evolves with them-at no additional cost. No subscriptions, no renewals, no paywalls.

Direct Instructor Support and Compliance Guidance

You are not learning in isolation. Our expert faculty-comprised of seasoned clinical investigation auditors and regulatory consultants-provides direct, responsive support. Submit your questions and receive detailed, role-specific guidance tailored to your project, device class, and region.

Certificate of Completion Issued by The Art of Service

Upon successful completion, you will earn a formal Certificate of Completion issued by The Art of Service. This credential is recognized globally by medtech employers, notified bodies, and regulatory review teams. It validates your mastery of ISO 14155 and strengthens your credibility in clinical affairs, quality assurance, and regulatory strategy roles.

Straightforward, Transparent Pricing – No Hidden Fees

The listed investment covers everything. There are no hidden charges, add-ons, or surprise costs. What you see is exactly what you get-full access, lifetime updates, support, and certification.

Accepted Payment Methods

We accept all major payment options, including Visa, Mastercard, and PayPal. Payments are securely processed with end-to-end encryption.

Enrollment Confirmation and Access Delivery

After enrollment, you will receive a confirmation email. Your access credentials and detailed course login instructions will be delivered separately once your enrollment is fully activated. This ensures data accuracy and a seamless onboarding experience for every learner.

Risk-Free with a 30-Day Satisfied or Refunded Guarantee

Your success is our priority. If you’re not completely satisfied with the course content, structure, or value within 30 days of enrollment, simply request a full refund. No questions, no hassle. We remove the risk so you can focus on the return.

Confidence-Building: “Will This Work for Me?”

We understand the doubt. You’ve seen “comprehensive” training that didn’t translate to real audits or submissions. This is different.

• This works even if you’re new to clinical investigations and need to rapidly upskill for an upcoming ISO 14155 audit.
• This works even if you’re a senior compliance officer navigating complex Class III device trials across multiple jurisdictions.
• This works even if your team is under audit pressure and needs immediate, actionable documentation improvements.
• This works even if your last clinical investigation was delayed due to protocol misalignment or sponsor oversight gaps.

From regulatory affairs specialists to clinical project managers and QA leads, professionals across 87 countries have used this program to deliver compliant, inspection-ready investigations. The tools, checklists, and frameworks are built from real submissions-real outcomes.

You’re not just learning a standard. You’re mastering a system that ensures your work stands up under scrutiny.

Module 1: Foundations of ISO 14155 and Clinical Investigation Governance

• Introduction to ISO 14155: Purpose, scope, and alignment with global regulations
• Differences between clinical investigations of medical devices and pharmaceuticals
• Key stakeholders: Sponsors, investigators, IRBs/ECs, and notified bodies
• Regulatory context: MDR, IVDR, FDA 21 CFR Part 812, and ISO 13485 integration
• National and international legal requirements for clinical investigations
• Device classification and its impact on investigation design and oversight
• The role of Good Clinical Practice (GCP) in medical device trials
• Ethical principles: Informed consent, patient safety, and confidentiality
• Lifecycle approach to clinical evaluation and investigation planning
• Understanding equivalence and its use in clinical data justification
• Overview of the EU Clinical Investigation application process
• FDA Investigational Device Exemption (IDE) requirements comparison
• Role of oversight committees: DSMBs, SAE review boards, and safety monitors
• Definition of a clinical investigation under ISO 14155
• When a clinical investigation is required vs. when literature suffices

Module 2: Sponsor Responsibilities and Quality Management Systems

• Defining the sponsor role under ISO 14155
• Establishing a Sponsor Quality Management System (QMS)
• Documented procedures for clinical investigation oversight
• Design and implementation of sponsor standard operating procedures (SOPs)
• Assigning key sponsor personnel: CPM, QA lead, medical monitor, biostatistician
• Delegation of responsibilities and maintaining oversight
• Selection and management of CROs and third-party vendors
• Contractual agreements with investigators and sites
• Sponsor responsibilities for monitoring, auditing, and inspection readiness
• Developing a risk-based monitoring strategy
• Investigator selection criteria and site qualification process
• Sponsor-led site initiation and training protocols
• Investigator file management and essential documentation control
• Ensuring compliance with ethics committee requirements
• Sponsor responsibilities for adverse event reporting
• Tracking and trending of sponsor audit findings

Module 3: Clinical Investigation Protocol Development

• Structure and content of an ISO 14155-compliant protocol
• Investigational plan: Objectives, endpoints, and success criteria
• Determining investigational device use: Feasibility, pivotal, or post-market
• Study design: Prospective, retrospective, randomized, or single-arm
• Sample size justification and statistical power analysis
• Inclusion and exclusion criteria development
• Control group selection: Historical, active comparator, or no control
• Randomization procedures and blinding strategies
• Primary and secondary endpoints: Defining and measuring outcomes
• Follow-up schedule and visit timeline design
• Risk management integration into protocol development
• Safety monitoring plan and interim analysis triggers
• Data collection tools: CRFs, eDiaries, and electronic source data
• Use of legacy devices and off-the-shelf equipment in studies
• Statistical analysis plan (SAP) development and integration
• Handling protocol amendments and version control
• Approval process: Ethics committee, IRB, and regulatory authority submission

Module 4: Investigator and Site Selection

• Criteria for selecting qualified investigators
• Assessing investigator experience with similar devices or indications
• Site qualification checklist and site assessment visits
• Review of site infrastructure: Equipment, staffing, and patient access
• Investigator CV and GCP training verification
• Conflict of interest disclosure and management
• Multi-site vs. single-center investigation planning
• Geographic diversity and patient recruitment feasibility
• Investigator agreement: Terms, indemnification, and compensation
• Site initiation visit (SIV) agenda and execution
• Training investigators on GCP, protocol, and safety reporting
• Essential document collection from sites
• Site file organization and compliance verification
• Ongoing site performance monitoring and intervention
• Site de-selection and closure procedures

Module 5: Informed Consent and Ethical Oversight

• Ethical principles in medical research: Belmont Report and Declaration of Helsinki
• Informed consent process: Timing, documentation, and re-consent
• Required elements of an ISO 14155-compliant consent form
• Translation and cultural adaptation of consent documents
• Consent for vulnerable populations: Minors, incapacitated adults, elderly
• Process for documenting participant withdrawal and data use
• Waiver of consent: When and how it can be justified
• Role of Institutional Review Boards (IRBs) and Ethics Committees (ECs)
• Submission package for EC/IRB review
• Tracking EC/IRB approvals and conditions
• Annual renewal and continuing review requirements
• Reporting unanticipated problems and protocol deviations to ECs
• Handling serious adverse events in ethical oversight
• Data privacy and GDPR/HIPAA compliance in consent design
• Use of digital consent platforms and eConsent
• Audit trail requirements for consent documentation

Module 6: Data Management and Integrity

• Data lifecycle management: From collection to archival
• Design and validation of Case Report Forms (CRFs)
• Electronic data capture (EDC) system selection and configuration
• Data validation rules and edit checks
• Source data verification (SDV) requirements and scope
• Query management and resolution process
• Double data entry and reconciliation procedures
• Data security: Access controls, encryption, and backups
• ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, + Complete
• Handling missing data: Imputation and sensitivity analysis
• Data management plan (DMP) structure and content
• Roles: Data manager, data entry clerk, database administrator
• Data transfer agreements with CROs and third parties
• Audit trails for data modifications and corrections
• Database lock procedures and finalization
• Regulatory expectations for data integrity in inspections
• Use of AI and automated tools for data cleaning (compliance review)

Module 7: Safety Reporting and Adverse Event Management

• Definitions: SAE, ADE, SUSAR, and device deficiencies
• Reporting timelines: 24-hour, 7-day, 15-day, and 30-day rules
• Global safety reporting requirements: EU, US, Canada, Australia, Japan
• Determining device- or procedure-relatedness
• Expedited vs. periodic safety reporting
• Development Safety Update Report (DSUR) preparation
• MedWatch, EudraVigilance, and other regulatory safety databases
• Individual Case Safety Report (ICSR) structure and content
• Causality assessment methodologies and documentation
• Safety data aggregation and signal detection
• Unexpected adverse device effects (UADE) and reporting
• Follow-up on incomplete or undetermined events
• Reporting to ethics committees and regulatory authorities
• Integration with post-market surveillance systems
• Training investigators on safety reporting responsibilities
• Tracking and trending safety data across sites
• Use of safety dashboards for executive reporting

Module 8: Monitoring and On-Site Oversight

• Types of monitoring: Remote, on-site, centralized, risk-based
• Developing a monitoring plan and monitoring schedule
• Pre-monitoring site review and preparation checklist
• Conducting site monitoring visits: Opening, fieldwork, closing
• Monitoring visit reporting: Findings, actions, and follow-ups
• Source data verification: Scope, methods, and documentation
• Evaluating investigator compliance with protocol and GCP
• Review of informed consent documentation and patient files
• Device accountability: Shipping, storage, use, and retrieval
• Adverse event reporting and reconciliation
• Data entry accuracy and query resolution status
• Investigator performance feedback and coaching
• Management of protocol deviations and violations
• Corrective and preventive action (CAPA) planning
• Monitoring visit frequency based on risk and site performance
• Use of monitoring templates and digital checklists
• Final monitoring report compilation and audit readiness

Module 9: Audit Preparation and Regulatory Inspection Readiness

• Differences between audit, inspection, and review
• Preparing for notified body audits under MDR/IVDR
• FDA pre-approval inspection (PAI) expectations
• Essential document list and verification
• Investigator site file (ISF) and sponsor file organization
• Compilation of regulatory submissions: CTA, IDE, CE dossier
• Inspection readiness self-audit checklist
• Mock audits: Conducting internal and external dry runs
• Assigning inspection team roles: Lead, SME, note-taker, response lead
• Handling document requests and data room setup
• Response strategy for findings and non-conformities
• Corrective action plans for audit findings
• Use of audit management software and tracking tools
• Audit trail validation and system compliance checks
• Training staff for inspection behavior and communication
• Post-inspection report review and closure
• Linking audit outcomes to continuous improvement

Module 10: Clinical Investigation Report (CIR) and Regulatory Submission

• Structure of an ISO 14155-compliant Clinical Investigation Report
• Executive summary: Concise, data-driven, and conclusion-focused
• Study objectives and endpoints: Revisiting protocol alignment
• Statistical methods and analysis interpretation
• Summary of safety, performance, and effectiveness data
• Adverse event tabulations and narrative summaries
• Graphical representation of key outcomes and trends
• Limitations and biases discussion
• Conclusion: Correlation to device benefit-risk profile
• Appendices: Raw data, tables, figures, and regulatory correspondence
• Peer review and medical writing standards
• Internal sign-off and quality control steps
• Formatting for CTA, IDE, and CE marking submissions
• Linking CIR to Post-Market Clinical Follow-up (PMCF)
• Drafting justification for equivalence claims using CIR data
• Use of CIR data in labeling and promotional claims
• Archival requirements: Retention period and storage compliance

Module 11: Integration with Post-Market Surveillance and PMCF

• Transitioning from pre-market to post-market clinical data
• Designing Post-Market Clinical Follow-up (PMCF) studies
• Alignment of PMCF with CER and Periodic Safety Update Reports
• Use of real-world data in PMCF: Registries, EHRs, wearables
• Risk-based approach to PMCF frequency and scope
• Feedback loop: Using market data to improve device design
• Updating clinical evaluation reports (CERs) with PMCF data
• Reporting obligations for long-term safety and performance
• Integration with vigilance and complaint handling systems
• Use of patient-reported outcomes (PROs) in PMCF
• Patient retention and follow-up strategies in long-term studies
• Digital tools for remote PMCF data collection
• Handling device modifications and new indications
• PMCF plan submission to notified bodies
• Statistical considerations for long-term data analysis
• Updating risk management files with PMCF insights
• Automated triggers for initiating new investigations

Module 12: Cross-Jurisdictional Compliance and Global Strategies

• Harmonization of ISO 14155 with FDA, Health Canada, TGA, PMDA
• Designing global investigations with multi-regional compliance
• Country-specific requirements for ethics submission and recruitment
• Cultural and language considerations in global trials
• Use of central IRBs vs. local ethics committees
• Translation and back-translation of key documents
• Data transfer regulations: GDPR, HIPAA, PIPL, and other frameworks
• Audit readiness across multiple regulatory systems
• Global safety reporting coordination
• Single protocol with regional addendums approach
• Managing diversity in patient populations and clinical practice
• Regulatory strategy: Target markets and staggered submissions
• Leveraging clinical data for multiple country approvals
• Role of global regulatory consultants and local representatives
• Cost and timeline optimization in global investigations
• Bridging studies and local data requirements
• Preparing for regulatory pre-submission meetings

Module 13: Risk Management Integration and Documentation

• Linking ISO 14155 to ISO 14971: Risk management for medical devices
• Identifying investigation-related hazards and risks
• Risk control measures in study design and protocol
• Residual risk evaluation and mitigation
• Integration of risk analysis into investigator training
• Device failure mode analysis in clinical settings
• Use of FMEA and fault tree analysis in protocol planning
• Monitoring risk controls during the investigation
• Updating the risk management file with clinical data
• Reporting risk-related incidents to regulatory bodies
• Interaction between clinical investigation risks and product risks
• Handling device deficiencies observed during trials
• Escalation procedures for critical risks
• Risk communication to investigators and participants
• Documentation trail for risk decisions and approvals
• Audit proofing risk management integration
• Leveraging risk data for PMCF planning

Module 14: Certification Project and Practical Implementation

• Final certification project: Develop a complete ISO 14155-ready investigation plan
• Step 1: Select a device and indication
• Step 2: Draft a compliant protocol with all required sections
• Step 3: Create a monitoring plan and risk-based strategy
• Step 4: Design a site selection and training process
• Step 5: Develop a safety reporting workflow
• Step 6: Build a data management and audit trail system
• Step 7: Compile essential documents checklist
• Step 8: Prepare a mock regulatory submission package
• Step 9: Conduct a self-audit using provided checklist
• Step 10: Submit for expert review and feedback
• Use of templates, checklists, and decision matrices
• Self-assessment quizzes for mastery verification
• Progress tracking dashboard and completion markers
• Final review and approval process
• Earning your Certificate of Completion
• Lifetime access to update your project as regulations evolve