PECB ISO 13485 Foundation study plan
PECB ISO 13485 Foundation · Give each week a clear focus.
8 weeks · About 6 hours per week
Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
Define what a medical device quality management system (MDQMS) is and explain why ISO 13485 exists separately from ISO 9001
Map the structure of ISO 13485 clause by clause and identify the clauses that carry the most weight on the Foundation exam
Distinguish the terms device, accessory, active device, implantable, and IVD diagnostic, and give one example of each
Explain the process approach and how the plan-do-check-act cycle applies to a device lifecycle
Your checkpoint
A one-page clause map of ISO 13485 with a five-line definition of an MDQMS and a glossary of 15 device terms written in your own words
Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
Describe the regulatory purpose of an MDQMS and how it supports conformity with medical device legislation
Explain the role of the quality management system in demonstrating safety and performance of devices
Differentiate mandatory regulatory requirements from voluntary standards adopted to satisfy them
Summarize how risk management principles underpin the whole standard rather than sitting in one clause
Your checkpoint
A 300-word written summary titled 'Why a device company needs an MDQMS' linking regulatory obligation, risk management, and the standard's requirements
Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
List the documented information required by ISO 13485 and classify each item as a procedure, record, or policy
Explain the difference between a quality manual, a documented procedure, and a record
Describe the requirements for document control and record control and why retention periods matter
Identify which records must be retained for at least the lifetime of the device as defined by the organization
Your checkpoint
A table of at least 20 required documents and records with their clause reference and whether each is a procedure or a record
Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS) & Medical Devices Quality Management System (MDQMS)
Explain management commitment, customer focus, and quality policy requirements under management responsibility
Describe how quality objectives are established, communicated, and reviewed
Outline the inputs, outputs, and follow-up actions of a management review
Identify the roles of top management and the quality management representative in the MDQMS
Your checkpoint
A mock management review agenda and minutes template covering all required inputs and outputs, plus a 10-question self-quiz scored at 80 percent or higher
Medical Devices Quality Management System (MDQMS)
Describe competence, training, awareness, and infrastructure requirements for personnel and facilities
Explain the requirements for the work environment and contamination control where relevant to device safety
Outline product realization from planning through design and development inputs, outputs, review, verification, and validation
Distinguish design verification from design validation and give a device example of each
Your checkpoint
A design and development checklist derived from the standard, with a short note on verification versus validation using one worked device example
Medical Devices Quality Management System (MDQMS)
Explain purchasing controls, supplier evaluation and selection, and verification of purchased product
Describe production and service provision controls including cleanliness, installation, and servicing activities
Outline identification, traceability, and the special traceability requirements for implantable devices
Describe how the organization handles customer property and preservation of product
Your checkpoint
A supplier evaluation and re-evaluation process flow with the records it generates, plus a traceability example for an implantable device
Medical Devices Quality Management System (MDQMS)
Describe the requirements for monitoring and measurement of product, including acceptance criteria and release of product
Explain control of nonconforming product, including identification, segregation, evaluation, and disposition
Outline the purpose and inputs of the complaint handling and regulatory reporting processes
Describe how internal audits are planned, conducted, and followed up
Your checkpoint
A nonconformance and corrective action case study written end to end, from detection through root cause to effectiveness check
Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS) & Medical Devices Quality Management System (MDQMS)
Explain the requirements for data analysis and how results feed improvement and management review
Describe corrective and preventive action requirements and how they differ from correction
Integrate all clauses into a single lifecycle narrative from design through post-market surveillance
Practice timed exam technique on scenario-based questions and review every wrong answer against the clause text
Your checkpoint
A full-length practice exam completed under time, with a written clause-reference justification for every incorrect answer and a final one-page revision sheet
Milestones
Week 2: Can state the purpose of an MDQMS and the difference from ISO 9001 without notes, scoring at least 80 percent on a 20-question domain 1 quiz
Week 4: Can list the required management review inputs and outputs and all mandatory documented procedures from memory
Week 6: Can walk through product realization from design to release, naming the clause that governs each step, with no more than two omissions
Week 8: Score 80 percent or higher on a timed full-length practice exam and explain the reasoning behind every missed question using a clause reference