CMDA study plan

Map the clause structure of ISO 13485:2016 by outlining all main clauses and listing at least two subclauses under each

Differentiate the scope and structure of FDA 21 CFR Part 820, EU MDR 2017/745, and ISO 13485 by building a three-column comparison table

Identify which quality system requirements attach to device classification and jurisdictional registration pathways

Explain the audit implications of key QMS elements (document control, management review, purchasing controls, CAPA linkage) in writing

Trace the ISO 14971 risk management process end to end (hazard identification, risk estimation, evaluation, control, residual risk, production/post-production monitoring) and list the audit evidence each step should produce

Distinguish design controls (design inputs, outputs, review, verification, validation, transfer, changes) and state the objective evidence an auditor would sample for each

Compare process validation approaches (prospective, concurrent, retrospective, revalidation) and match each to a device manufacturing scenario

Relate risk management outputs to QMS requirements such as design controls, CAPA, and supplier controls

Sequence a full design control audit trail from design input through design transfer, naming the record type expected at each stage

Evaluate risk acceptability criteria and risk control measure verification against ISO 14971 expectations

Differentiate verification from validation and identify common audit findings associated with each

Assess process validation documentation (protocol, IQ/OQ/PQ, acceptance criteria, deviation handling) for completeness

Explain software and sterilization validation considerations and their audit evidence

Construct opening and closing meeting agendas that satisfy audit protocol expectations

Formulate at least 20 open-ended interview questions mapped to QMS clauses, avoiding leading phrasing

Differentiate objective evidence types (records, observation, interview corroboration) and classify ten sample evidence items correctly

Apply sampling logic (random, judgmental, stratified) to a mock audit scenario and justify the chosen approach in writing

Demonstrate note-taking that links each observation to criterion, evidence, and record identifier

Draft an audit plan (scope, criteria, objectives, schedule, team roles, sampling strategy) for a mock device manufacturer

Build an audit checklist of at least 25 items traceable to specific clauses and to identified process risks

Contrast audit types (internal, supplier, certification, surveillance, for-cause, product, process) and their defining characteristics

Define scope, criteria, and objective evidence in audit terms and distinguish audits from inspections and assessments

Explain audit principles (independence, integrity, evidence-based approach, due professional care)

Classify at least 15 written observations into major nonconformity, minor nonconformity, observation, and opportunity for improvement with justification

Write nonconformity statements in the criterion-evidence-conclusion format

Outline corrective action expectations: root cause analysis, correction vs. corrective action vs. preventive action, effectiveness verification

Design a CAPA follow-up tracker that records due dates, verification method, and closure evidence

Draft a findings report structure including distribution, grading definitions, and response timelines

Design an audit program covering risk-based scheduling, resource allocation, and program performance monitoring

Define auditor competence criteria (education, training, experience, technical knowledge, personal attributes) and evaluate a mock auditor profile against them

Apply auditor ethics principles to three ethical-dilemma scenarios and justify the correct course of action

Distinguish the roles of lead auditor, auditor, technical expert, and auditee in a written role chart

Explain audit program records and the use of audit results in management review

Synthesize all domains by completing a timed 100-question mock exam

Analyze every missed item by domain and root cause (knowledge gap vs. misreading)

Revisit the two lowest-scoring domains with targeted re-study

Recite core definitions, clause numbers, and classification rules from memory