Free lesson previews

Objectives, key takeaways and a free practice question for each lesson.

AI in medical devices

• AI and machine learning landscape in healthcare: device types, claims and stakeholders
• Regulatory landscape for AI medical devices across the EU, US, UK and Israel
• Cybersecurity for AI devices: threat modelling, adversarial attacks and secure design
• Premarket cybersecurity documentation, SBOM and postmarket vulnerability handling
• Post-market monitoring of AI: performance drift, data collection and triggers
• Vigilance, update release and communication for learning and static models
• Technical documentation for AI devices: what the notified body and FDA expect
• Building the AI technical file: model card, data sheet and traceability matrix
• Using AI tools safely in QA/RA work: validation of tools, confidentiality and records
• Practical AI use cases in document control, audits and regulatory intelligence with review controls
• EU AI Act structure: risk tiers, high-risk systems and the Digital Omnibus timelines
• AI Act obligations for providers of medical device AI and the interaction with MDR notified bodies
• FDA approach to AI-enabled devices: submission content, PCCP and transparency
• FDA lifecycle guidance for AI software: performance monitoring and change control
• Integrating AI governance into the QMS: ISO 13485 and ISO/IEC 42001 mapping
• AI policy, roles, objectives and AI-specific procedures and records
• AI risk management with ISO 14971 and ISO/IEC 23894: hazards unique to AI
• Bias, drift, misuse and human factors risk controls with worked examples
• Data governance: sourcing, representativeness, labelling and data quality for AI devices
• Data splitting, leakage, privacy and data management records for audit
• AI development lifecycle: requirements, model design and IEC 62304 alignment
• Configuration management, MLOps controls and change management for models
• Verification and validation of AI: performance metrics, test sets and acceptance criteria
• Clinical validation, subgroup performance, robustness and reporting of results
• Human oversight and transparency: instructions for use, user interfaces and training
• Explainability, automation bias and monitoring of human-AI interaction
• Capstone part 1: review of a fictional AI device file
• Capstone part 2: findings, risk-based conclusions and an improvement plan

ISO 13485

• Capstone part 1: audit case file review of a fictional manufacturer, findings and evidence
• Capstone part 2: writing nonconformities, grading and the closing meeting
• Opening meeting, evidence collection and sampling - ISO 19011 clauses 6.4.3 and 6.4.7 and ISO 13485 clause 8.2.4
• Interviewing, observation and remote audits - ISO 19011 clauses 6.2.3 and 6.4.7 and ISO 13485 clause 8.2.4
• Closing meeting, audit report and conclusions - ISO 19011 clauses 6.4.8 to 6.5 and ISO 13485 clause 8.2.4
• Follow-up: verifying corrective actions and CAPA effectiveness
• Auditor competence, ethics and continual development
• Auditing clause 4: QMS, documents, records and QMS software
• Auditing clause 5: management commitment, planning and review
• Auditing clause 6: competence, infrastructure and work environment
• Auditing clauses 7.1 to 7.3: planning, customer requirements and design control
• Auditing clauses 7.5 and 7.6: production, validation, traceability and calibration
• Auditing clause 8: feedback, complaints, reporting, nonconforming product and CAPA
• MDR conformity assessment for auditors: Annex IX, Annex XI and notified body certificates
• Auditing the MDR QMS (Article 10(9)) and the GSPR (Annex I)
• Auditing technical documentation (Annex II and III) and clinical evaluation
• Auditing PMS, PMCF, PSUR and vigilance (MDR Articles 83 to 92)
• Auditing UDI, EUDAMED, labelling and economic operators (MDR Articles 13 to 16 and 27 to 33)
• Notified body audit conduct: unannounced audits, sampling and nonconformity handling
• FDA QMSR (21 CFR 820) for auditors: structure, differences from ISO 13485 and inspection process
• Mock FDA inspection and inspection-readiness audit
• MDSAP for auditors: audit model, chapters, grading and the five-day rule
• Auditing the ISO 14971 risk management file
• Auditing sterilisation, bioburden and packaging validation
• Auditing clean rooms and environmental monitoring
• Auditing medical device software and QMS software (IEC 62304, cybersecurity, Part 11)
• AI in medical devices I: EU AI Act high-risk obligations and the Digital Omnibus timeline
• AI in medical devices II: FDA PCCP, GMLP, data governance, validation and human oversight
• Capstone: integrated internal audit of a fictional company file
• What a device history record is and what it must show - clauses 7.5.1, 7.5.8 and 7.5.9
• Compiling the batch record - line clearance, in-process checks, deviations, nonconforming product, release and electronic records
• DHR audit practice - reviewing a batch record, reconciliation, planted errors, the traceability test and DHR versus DMR
• What a DMR is today - 21 CFR part 820 (QMSR), ISO 13485 clause 4.2.3 and the contents of the device file
• Building and controlling the device file - structure, index, change control, approvals and links to the design file and technical documentation
• Auditing the device file - sampling, traces, common findings, and DMR versus DHR, DHF and technical file
• Why quality systems exist: medical device history, regulators and the lifecycle
• Quality vocabulary and the regulatory map: ISO 13485, MDR, QMSR and MDSAP in one view
• Clause 4 - QMS requirements, process maps, quality manual and document control
• Clause 4.2.5 - control of records and good documentation practice
• Clauses 5-6 - management responsibility and resource management
• Clause 7.1 - planning of product realization and risk management
• Clause 7.3 - design and development: phases, deliverables and traceability
• Clauses 7.2 and 7.4 - customer requirements and purchasing
• Clause 7.5 - production and service provision, identification and traceability
• Clauses 7.5.6 and 7.6 - process validation and measuring equipment (overview)
• Clause 8 - measurement, analysis and improvement (feedback, audits, nonconformity, CAPA)
• Design and development planning, inputs and outputs - clauses 7.3.2 to 7.3.4
• Design review, verification, validation, transfer and change - clauses 7.3.5 to 7.3.10 and the DHF
• Risk management process: hazards, hazardous situations and risk estimation under ISO 14971
• Risk control, residual risk, the risk management file and production and post-production feedback
• When and why to validate - clauses 7.5.6 and 4.1.6, the GHTF decision tree and the validation master plan
• IQ and OQ in depth - installation checks, worst case challenge, process window and protocol structure
• Performance qualification in depth: sample size, acceptance criteria and the validated state
• Validating a pouch sealer end to end, and auditing clause 7.5.6
• Sterilization methods overview: EtO, gamma, steam and the ISO 11135, 11137 and 17665 families
• Bioburden, sterility assurance level, endotoxin and LAL testing in routine control
• Packaging design and material selection under ISO 11607-1 and sterile barrier systems
• Packaging validation under ISO 11607-2: sealing, ageing, transport and integrity testing
• Complaint handling and corrective action - clauses 8.2.2, 8.3 and 8.5.2
• Preventive action, advisory notices and recalls - clauses 8.3.3, 8.5.3 and vigilance links
• Supplier selection and evaluation - clause 7.4.1 and the approved supplier list
• Purchasing information, verification of purchased product and supplier quality agreements
• Internal audit programme and management review inputs and outputs - clauses 8.2.4 and 5.6
• Management review in practice: data, decisions, actions and records
• IEC 62304 software lifecycle, safety classes and development planning
• Software verification, maintenance, problem resolution and cybersecurity links

FDA

• Choosing the pathway - premarket notification, substantial equivalence, predicates and the alternatives
• Building the submission - 21 CFR 807 subpart E content, performance testing, comparison table, labeling and the 510(k) summary
• The review process - acceptance review, substantive review, AI requests, MDUFA timelines and why 510(k)s stall
• What eSTAR is - the template, who must use it, and how it reaches FDA
• Completing the eSTAR - section by section, attachments and the form checks
• Submitting and managing an eSTAR - Portal upload, holds, requests and the planted-error case

Integrated management systems

• ISO 14001 context, aspects and compliance obligations
• ISO 14001 leadership, objectives, support and operational control
• ISO 14001 performance evaluation, improvement and integration
• ISMS foundations - context, scope, leadership and the CIA triad
• Planning and support - risk, Statement of Applicability, Annex A and documented information
• Operation, evaluation and improvement - audits, certification and the medical-device link
• ISO 9001 basics 1 - Context, scope and the process approach
• ISO 9001 basics 2 - Leadership, planning and support
• ISO 9001 basics 3 - Operation, evaluation and improvement

ISO 42001

• AIMS foundations - what ISO/IEC 42001 is, context, leadership and the AI policy
• Planning and support - AI risk, AI system impact, objectives, competence and documented information
• Operation, performance, improvement and Annexes - running, auditing and certifying an AIMS

EU MDR

• IVDR scope, classification and the structure of the technical file - Regulation (EU) 2017/746, Annex VIII, Annexes II and III
• IVD-specific content - performance evaluation, stability, traceability, GSPR, common specifications and transitional dates
• Notified body assessment of the IVDR file, PMPF, the summary of safety and performance and typical deficiencies
• General safety and performance requirements (Annex I) and the conformity assessment routes
• Clinical evaluation, UDI, EUDAMED and the person responsible for regulatory compliance (Article 15)
• Post-market surveillance system, PMS plan, PSUR and trend reporting
• PMCF, serious incident reporting, field safety corrective actions and timelines
• QMSR and FDA inspection readiness: what changed on 2 February 2026 and how inspections run
• Establishment registration, device listing, MDR reporting and corrections and removals
• Technical documentation per MDR Annexes II and III: structure, GSPR checklist and common deficiencies
• Notified body technical file assessment, sampling and responding to deficiencies
• Capstone part 1: review of a fictional technical file and evidence map
• Capstone part 2: reviewer report, nonconformities and certification decision
• Structure of the MDR technical file - Annex II, Annex III and how notified bodies expect it laid out
• Building each section - GSPR checklist, risk file link, V&V summaries, labelling and the PMS plan
• Notified body review of the technical file - sampling, typical deficiencies, change control and keeping it current
• MDR and IVDR orientation: economic operators, scope and the path to CE marking
• Classification under MDR Annex VIII and IVDR Annex VIII rules with fictional examples

MDSAP

• Auditing organizations and governance - Regulatory Authority Council, recognition, certificates and impartiality
• MDSAP and ISO 13485:2016 - the clause crosswalk and where MDSAP adds more
• Preparing for your first MDSAP audit - readiness, country matrix, document pack and mock questions
• Basic case study - Brannock Spinal Systems first-cycle audit
• Chapter 1 Management - eleven tasks: policy, representative, resources, outsourcing, risk planning and management review
• Chapter 2 Device marketing authorization and facility registration - evidence, changes and notification
• Chapter 3 Measurement, analysis and improvement - sixteen tasks: data, CAPA, complaints, internal audit, nonconforming product
• Chapter 4 Adverse events and advisory notices - reportability, timeframes by country and recalls
• Chapter 5 Design and development - seventeen tasks: planning, inputs, V&V, software, clinical evaluation, change and transfer
• Chapter 6 Production and service controls - twenty-nine tasks, process validation and sterile devices (Annex)
• Chapter 7 Purchasing - twelve tasks: supplier evaluation, purchasing data, critical suppliers and verification
• United States - 21 CFR 820 (QMSR), 803, 806, 807 and 830, and how FDA uses MDSAP reports
• Canada - Medical Devices Regulations SOR/98-282, licences, mandatory problem reporting and recalls
• Brazil - ANVISA RDC 665/2022, RDC 687/2022 B-GMP certification and registration holder duties
• Japan - MHLW Ministerial Ordinance 169 as amended, PMDA, the marketing authorization holder and QMS inspections
• Australia - TGA, TG(MD)R Schedule 3, sponsor-manufacturer agreements and conformity assessment evidence
• Writing nonconformities in MDSAP style - requirement, evidence, finding, the 5W2H and the so-what
• Responding to findings - remediation plans, root cause, effectiveness, 15 and 30 day rules and appeals
• The audit report package - AU F0019.1 report, F0019.2 grading form, guidelines G0019.3 and G0019.4, policy P0019 and P0027
• Regulatory authority exchange - how FDA, Health Canada, ANVISA, PMDA and TGA use reports, special audits and escalations
• MDSAP and EU MDR/IVDR - what MDSAP does not cover, MDCG 2020-14 and integrated audit strategy
• Change and transition - QMSR 2026, Audit Approach revisions, RDC 665, MO 169 and keeping a multi-regulation QMS current
• Audit task workshop - chapter by chapter document audits with planted nonconformities and grading drills
• Capstone A - mock MDSAP audit: planning, opening meeting, Management and Measurement chapters
• Capstone B - mock MDSAP audit: Design, Production, Purchasing, grading, closing meeting and report package

Trading

• Trading practitioner: building a rules-based plan, risk per trade and position sizing
• Trading practitioner: journalling, review metrics and a demo practical
• Trading expert: strategy testing, drawdown control and psychology of discipline
• Trading expert capstone: a complete demo-account strategy review

Educational only, not legal or financial advice. Trading involves risk of loss.