ISO 13485:2016 Medical Device Quality Management Systems Lead Implementer Training and Certification Program

Programme Summary

Practise leading a structured medical device quality implementation project against ISO 13485:2016. Working through a medical device manufacturer case, participants translate device lifecycle controls, regulatory interfaces and traceable records into accountable controls, resources and measurable milestones. The programme develops an implementation portfolio, tests operational feasibility and prepares management review evidence to support reliable medical device processes and controlled regulatory evidence.

Training Objectives

1 Structure medical device quality implementation leadership; 2 Translate requirements into workable controls; 3 Coordinate ownership resources and project milestones; 4 Establish meaningful measures and review evidence; 5 Prepare implementation priorities for management approval.

Learning Outcomes

1 Build a medical device quality implementation roadmap; 2 Specify controls for unvalidated critical processes; 3 Design design and validation records; 4 Assign accountable owners and measurable milestones; 5 Present a justified management review proposal.

Target Audience

Medical Device Quality Managers; Regulatory Affairs Managers; Validation Engineers; Implementation Project Managers; Management System Consultants.

Target Industries

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

Course Contents

• Module 1 Implementation Leadership and Project Mandate: Business case scope and intended benefits; Sponsor responsibilities and implementation team roles; Constraints resources and governance decisions.
• Module 2 Diagnostic Review and Implementation Priorities: Requirements mapping and baseline evidence; Risk based gaps and priority decisions; Implementation milestones and acceptance criteria.
• Module 3 Device Scope and Regulatory Interfaces: Device lifecycle roles and organisational scope; Applicable regulatory requirements and responsibilities; Risk based control of quality processes.
• Module 4 Quality Documentation and Accountability: Quality manual and documented procedures; Medical device files and record retention; Management responsibility and quality planning.
• Module 5 Resources and Controlled Work Environments: Personnel competence and training evidence; Infrastructure maintenance and contamination controls; Work environment and product cleanliness.
• Module 6 Design and Development Controls: Planning inputs outputs and reviews; Verification validation and design transfer; Design changes and development records.
• Module 7 Purchasing and Supplier Quality: Supplier selection and risk proportionate monitoring; Purchasing specifications and change communication; Verification of purchased products.
• Module 8 Production Validation and Traceability: Validated processes and software applications; Identification traceability and preservation controls; Installation servicing and sterile process interfaces.
• Module 9 Feedback Complaints and Reporting: Feedback collection and complaint evaluation; Regulatory reporting interfaces and escalation; Nonconforming product investigation and disposition.
• Module 10 Measurement and Quality System Improvement: Monitoring measurement and data analysis; Corrective and preventive action controls; Internal audit and management review evidence.
• Module 11 Designing the Implementation Architecture: Process interactions and accountable control owners; Integration with existing management arrangements; Proportionate documentation and practical control design.
• Module 12 Operational Control Design Workshop: Preventing unvalidated critical processes; Addressing incomplete device traceability; Responding to delayed complaint escalation.
• Module 13 Building the Required Evidence Portfolio: Design and validation records; Supplier qualification files; Complaint and corrective action records.
• Module 14 Competence Communication and Organisational Adoption: Role based competence and learning needs; Operational communication and stakeholder engagement; Resistance escalation and management support.
• Module 15 Resources Suppliers and Implementation Scheduling: Resource estimates and implementation dependencies; External support and supplier accountability; Controlled milestones and progress reporting.
• Module 16 Piloting Controls and Managing Changes: Pilot objectives and realistic acceptance checks; Operational feedback and control adjustments; Approval communication and controlled change records.
• Module 17 Monitoring Performance and Demonstrating Effectiveness: Measurable indicators and reliable data sources; Control performance and exception reporting; Evidence based decisions and corrective action.
• Module 18 Internal Assurance and Management Review: Internal audit planning and independence; Review inputs decisions and resource commitments; Readiness gaps and continuing improvement priorities.
• Module 19 Maintaining the Management System: Ownership handover and ongoing monitoring; Changing risks obligations and operating conditions; Learning mechanisms and improvement programme.
• Module 20 Implementation Portfolio and Leadership Simulation: Present controls responsibilities and milestones; Defend priorities using supplied evidence; Respond to management challenge and feedback.

Assessment

• 100 single best answer questions, including applied scenarios; one mark per question.
• 150 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 (90 minutes): Using a medical device manufacturer case, develop a medical device quality plan and implementation roadmap, assign resources and milestones, demonstrate one control and defend implementation priorities in a brief panel review.
• Assessment criteria: Workable design of controls for unvalidated critical processes; Relevant evidence portfolio including design and validation records; Feasible sequencing ownership and measurable implementation acceptance criteria.
• Pass each component separately: 75/100 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 implementation planning skills in medical device quality; it does not confer independent personnel certification or guarantee 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

555

Total teaching hoursTotal teaching hoursTotal teaching hours

35 hours; breaks, pre course work and formal final assessments excluded.35 hours; breaks, pre course work and formal final assessments excluded.35 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

Working knowledge of ISO 13485:2016, relevant medical device quality experience and familiarity with project planning are required. Participants should understand process ownership and operational controls.Working knowledge of ISO 13485:2016, relevant medical device quality experience and familiarity with project planning are required. Participants should understand process ownership and operational controls.Working knowledge of ISO 13485:2016, relevant medical device quality experience and familiarity with project planning are required. Participants should understand process ownership and operational controls.

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

Complete a 45-minute gap diagnostic using supplied design and validation records; identify priorities, process owners and implementation constraints.Complete a 45-minute gap diagnostic using supplied design and validation records; identify priorities, process owners and implementation constraints.Complete a 45-minute gap diagnostic using supplied design and validation records; identify priorities, process owners and implementation constraints.

End of course assessmentEnd of course assessmentEnd of course assessment

100 question written exam (150 minutes) and individual applied task (90 minutes).100 question written exam (150 minutes) and individual applied task (90 minutes).100 question written exam (150 minutes) and individual applied task (90 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.