ISO 13485:2016 Medical Device Quality Management Systems Foundation Level Training and Certification Program

Programme Summary

Build an understanding of medical device quality using ISO 13485:2016. Participants connect device lifecycle controls, regulatory interfaces and traceable records with responsibilities and performance measures. Exercises based on a medical device manufacturer case develop requirement interpretation, evidence selection and gap recognition. The programme establishes a foundation for reliable medical device processes and controlled regulatory evidence and further implementation or auditor development.

Training Objectives

1 Explain medical device quality requirements; 2 Connect requirements with operational responsibilities; 3 Recognise unvalidated critical processes; 4 Select relevant implementation evidence; 5 Prepare for further practical development.

Learning Outcomes

1 Map device lifecycle responsibilities; 2 Identify applicable regulatory interfaces; 3 Distinguish verification from validation evidence; 4 Trace device and supplier records; 5 Evaluate complaint and corrective action controls.

Target Audience

Medical Device Quality Managers; Regulatory Affairs Managers; Validation Engineers; Production Managers; Management System Coordinators.

Target Industries

Medical Device Manufacturing; Diagnostic Device Manufacturing; Device Contract Manufacturing; Medical Device Distribution; Device Servicing.

Course Contents

• Module 1 Standard Purpose and Practical Application: Management system purpose and intended outcomes; Requirement guidance and evidence distinctions; Course case scope and learning responsibilities.
• Module 2 Device Scope and Regulatory Interfaces: Device lifecycle roles and organisational scope; Applicable regulatory requirements and responsibilities; Risk based control of quality processes.
• Module 3 Quality Documentation and Accountability: Quality manual and documented procedures; Medical device files and record retention; Management responsibility and quality planning.
• Module 4 Resources and Controlled Work Environments: Personnel competence and training evidence; Infrastructure maintenance and contamination controls; Work environment and product cleanliness.
• Module 5 Design and Development Controls: Planning inputs outputs and reviews; Verification validation and design transfer; Design changes and development records.
• Module 6 Purchasing and Supplier Quality: Supplier selection and risk proportionate monitoring; Purchasing specifications and change communication; Verification of purchased products.
• Module 7 Production Validation and Traceability: Validated processes and software applications; Identification traceability and preservation controls; Installation servicing and sterile process interfaces.
• Module 8 Feedback Complaints and Reporting: Feedback collection and complaint evaluation; Regulatory reporting interfaces and escalation; Nonconforming product investigation and disposition.
• Module 9 Measurement and Quality System Improvement: Monitoring measurement and data analysis; Corrective and preventive action controls; Internal audit and management review evidence.
• Module 10 Interpreting Requirements in Context: Mandatory requirements and proportionate application; Interfaces with applicable legal obligations; Supported judgements and unresolved interpretation issues.
• Module 11 Selecting Relevant Management System Evidence: Design and validation records; Supplier qualification files; Complaint and corrective action records.
• Module 12 Foundation Application Workshop: Map responsibilities within the supplied case; Match controls to relevant requirements; Explain gaps and practical next steps.

Assessment

• 60 single best answer questions, including applied scenarios; one mark per question.
• 90 minute invigilated digital examination with identity verification. Approved accessibility adjustments preserve the assessed competence.
• Clean standard text and supplied case documents permitted; internet, messaging and external AI tools prohibited.
• Individual applied assessment (45 minutes): Using a supplied medical device manufacturer case, produce a device process map and evidence register, link three controls to relevant requirements and explain one unresolved weakness.
• Assessment criteria: Accurate interpretation of medical device quality requirements; Relevant use of design and validation records; Clear connection between controls responsibilities and identified gaps.
• Pass each component separately: 45/60 written marks (75%) and at least 70% on the applied task.
• All mandatory criteria must pass: Do not fabricate evidence or knowingly present unsupported conformity conclusions.
• Individual results and feedback are provided. One reassessment may follow coaching under the published enrolment terms.

Certification

• Successful learners receive a TQCSI Arabia digital Certificate of Successful Completion.
• The certificate records the learner name, exact programme title, teaching hours, completion date and unique verification reference.
• Verified identity, full attendance and separate written and applied passes are required; all mandatory critical criteria must be met.
• Proposed issue target: within 30 calendar days of approved results and settlement of applicable fees.
• Records assessed foundation knowledge of medical device quality; it does not establish professional auditor status, independent personnel certification or organisational certification.
• Attendance confirmation may record completed hours for unsuccessful learners; it does not certify successful completion.

Programme Profile

Number of daysNumber of daysNumber of days

333

Total teaching hoursTotal teaching hoursTotal teaching hours

18 hours; breaks, pre course work and formal final assessments excluded.18 hours; breaks, pre course work and formal final assessments excluded.18 hours; breaks, pre course work and formal final assessments excluded.

Delegates allowedDelegates allowedDelegates allowed

Maximum 20 delegates.Maximum 20 delegates.Maximum 20 delegates.

Training prerequisitesTraining prerequisitesTraining prerequisites

No formal qualification required. Familiarity with medical device quality activities and everyday business processes is recommended.No formal qualification required. Familiarity with medical device quality activities and everyday business processes is recommended.No formal qualification required. Familiarity with medical device quality activities and everyday business processes is recommended.

Pre course assignment and assessmentPre course assignment and assessmentPre course assignment and assessment

Complete a 20-minute diagnostic and identify how design and validation records support a supplied operational case.Complete a 20-minute diagnostic and identify how design and validation records support a supplied operational case.Complete a 20-minute diagnostic and identify how design and validation records support a supplied operational case.

End of course assessmentEnd of course assessmentEnd of course assessment

60 question written exam (90 minutes) and individual applied task (45 minutes).60 question written exam (90 minutes) and individual applied task (45 minutes).60 question written exam (90 minutes) and individual applied task (45 minutes).

Passing criteriaPassing criteriaPassing criteria

75% written and 70% applied, passed separately; full attendance. All mandatory criteria must pass.75% written and 70% applied, passed separately; full attendance. All mandatory criteria must pass.75% written and 70% applied, passed separately; full attendance. All mandatory criteria must pass.