AptSkill MedTech
Medical Device Resource Library
Every guide, topic, course and exam-prep resource in one place, grouped by what you are trying to do.
18 pages
Guides
In-depth regulatory and quality guides: FDA 510(k), QMSR, ISO 14971, IEC 62304, EU MDR and more.
- 510(k) Submission ProcessA clear guide to the FDA 510(k) submission process: when you need one, how to choose a predicate, what to include and...
- Expert Guide to US 510(k)Expert guidance on preparing a US FDA 510(k): strategy, substantial equivalence, testing evidence and common pitfalls...
- 510(k) Deficiency LettersThe 5 most common issues in FDA 510(k) deficiency letters and how to respond within the deadline without delaying you...
- Selecting a Predicate DeviceAn advanced guide to selecting the right predicate device for your FDA 510(k): intended use, technological characteri...
- 510(k) for SoftwareHow the FDA 510(k) process applies to software medical devices: documentation expectations, testing and cybersecurity...
- QMSR Implementation ChecklistA practical checklist for implementing the FDA's QMSR: what changes from the QSR, gap-analysis steps and how it affec...
- FDA QSIT InspectionsWhat to expect from an FDA QSIT inspection and how to prepare, updated for QMSR in 2026: subsystems, records and insp...
- Risk Management (ISO 14971)A practical guide to medical device risk management under ISO 14971: hazard analysis, risk control, evaluation and th...
- ISO 14971 Case StudiesReal-world ISO 14971 case studies showing how medical device teams identify hazards, control risk and document decisi...
- Is My Software a Medical Device?How to decide whether your software is a medical device: intended use, qualification criteria and what it means for c...
- Medical Device CybersecurityMedical device cybersecurity explained: regulatory expectations, threat modelling, secure design and documentation fo...
- EU MDR Technical DocumentationHow strong teams prepare EU MDR technical documentation that passes notified body review first time: structure, evide...
- PMCF Under EU MDRHow to design post-market clinical follow-up (PMCF) studies under EU MDR that generate regulatory-grade evidence for...
- EU MDR Compliance ChallengesWhy medical device professionals struggle with EU MDR compliance, and practical ways to fix the most common problems.
- What Counts as SOUP (IEC 62304)What counts as SOUP (software of unknown provenance) under IEC 62304, with examples for medical device software teams.
- SOUP Safety Classes A/B/CHow software safety classes A, B and C under IEC 62304 affect your SOUP requirements and documentation.
- SOUP Assessment GuideHow to assess SOUP under IEC 62304: what to evaluate, how to document it and how to link it to risk management.
- SOUP Assessment TemplateA SOUP assessment template for IEC 62304 to help you document software of unknown provenance consistently and audit-r...
25 pages
Topics
Core medical device topics explained: design controls, validation, post-market, CAPA, labeling, reimbursement and AI-enabled devices.
- Design Controls & Design QualityHow design controls work under FDA and ISO 13485: inputs, outputs, verification, validation, transfer and the design...
- Process Validation (IQ, OQ, PQ)When validation is required, how IQ, OQ and PQ fit together, how to set acceptance criteria and sample sizes, and how...
- Sampling Plan GenerationGenerate defensible sampling plans for verification, validation and inspection, with worked confidence and reliabilit...
- Post-Market Surveillance (PMS)Build a PMS system: PMS plan, PMS report and PSUR under EU MDR, FDA complaint and adverse event reporting, indicators...
- Software Validation (CSV / CSA)What software needs validation, how FDA's risk-based Computer Software Assurance works, and how to document validatio...
- EU Regulations (MDR / IVDR)A clear map of the EU MDR and IVDR: roles, classification, conformity assessment, CE marking, EUDAMED, UDI and transi...
- US FDA RegulationsHow FDA classifies devices, which pathway applies (510(k), De Novo, PMA), what every manufacturer must do, and where...
- ISO 13485 & MDSAP Audit ReadinessHow ISO 13485, MDSAP and FDA inspections fit together, plus a practical audit-readiness programme covering CAPA, supp...
- CAPA & Complaint HandlingA clear process for complaint handling, reportability, CAPA, root cause analysis and effectiveness checks that stand...
- Usability Engineering (IEC 62366)IEC 62366-1 and FDA human factors explained: use specification, use-related risk analysis, formative and summative ev...
- Clinical Evaluation (EU MDR)Write an EU MDR clinical evaluation report: CEP contents, literature search, equivalence, when a clinical investigati...
- UDI (EU & FDA)UDI-DI, Basic UDI-DI and UDI-PI explained, with FDA GUDID and EUDAMED requirements, the 2026 mandatory-use dates and...
- Supplier Controls & PurchasingRisk-based supplier qualification, quality agreements, incoming inspection, SCARs and monitoring under ISO 13485 clau...
- Biocompatibility (ISO 10993)ISO 10993-1 biological evaluation explained: contact categories, endpoints, chemical characterisation, BEP and BER, a...
- AI-Enabled Devices & PCCPFDA and AI-enabled devices explained: predetermined change control plans, lifecycle management, what is final versus...
- IDE & Device Clinical StudiesFDA IDE explained: significant vs non-significant risk, sponsor and investigator duties, IRB review, ISO 14155 and a...
- FDA De Novo GuideFDA De Novo explained: when to use it, direct vs post-510(k) routes, contents of a request, mandatory eSTAR, user fee...
- Device Labeling (FDA)FDA device labeling explained: 21 CFR 801, UDI, misbranding, QMSR section 820.45 labeling and packaging controls and...
- US Device ReimbursementUS device reimbursement explained: coverage, coding and payment, NTAP, TCET, parallel review and the proposed CMS RAP...
- Training by RolePick medical device training by role: regulatory, quality, R&D, validation, clinical, software, post-market and sales...
- SaMD TrainingWhat good Software as a Medical Device training covers: qualification, IEC 62304, cybersecurity and AI/PCCP lifecycle...
- ISO 13485 / QMSR TrainingWhat ISO 13485 and FDA QMSR training should cover for US manufacturers after the February 2026 compliance date, and w...
- RA Certificate TrainingWhat a regulatory affairs certificate course for medical devices should teach, who it suits, and how it compares with...
- FDA PCCP Guidance for SaMDHow to write an FDA predetermined change control plan for AI-enabled SaMD: the three PCCP sections, the modification...
- CDM & PV TrainingWhy clinical data management and pharmacovigilance are taught together for medical device and combination product tea...
14 pages
Careers
Career roadmaps and interview questions with ideal answers for regulatory, quality, clinical and software roles.
- US Regulatory Affairs Jobs GuideHow to land your first medical device regulatory affairs job in the US in 2026: skills, certifications, resume tips a...
- RA Interview QuestionsTop 10 interview questions for medical device regulatory affairs roles, with expert answers to help you prepare.
- QA Interview Q&A and Case StudiesQA and QMS interview questions with model answers and case studies on audit findings and complaint trends. Prepare fo...
- Design & Risk Interview Q&ADesign controls and ISO 14971 interview questions with model answers and case studies on risk controls and late desig...
- Validation Engineer Interview Q&AProcess, sampling and software validation interview questions with model answers and case studies on protocols and su...
- RA Interview Case Studies (EU & FDA)EU MDR and FDA regulatory affairs interview questions with model answers and three case studies with ideal answers.
- PMS & Vigilance Interview Q&APMS, vigilance and complaint handling interview questions with model answers and case studies on reportability and tr...
- Supplier Quality Interview Q&AEight supplier quality interview questions with model answers and three case studies: failed sole-source audit, inspe...
- Clinical Affairs Interview Q&AClinical evaluation and clinical affairs interview questions with model answers and case studies on legacy evidence,...
- SaMD & Software Quality Interview Q&AIEC 62304, SOUP, cybersecurity and CSA interview questions with model answers and three case studies: hotfix, vulnera...
- Quality Manager Interview Q&AEight quality leadership interview questions with model answers and case studies on shipping pressure, an FDA inspect...
- Product Development Interview Q&ADesign controls, usability, materials and UDI interview questions with model answers and three medical device R&D cas...
- Career Mentoring RoadmapHow mentoring works in MedTech regulatory and quality careers, typical paths, what to ask a mentor, and a 12-month pl...
- Success StoriesRead success stories and testimonials from professionals who trained with AptSkill MedTech.
4 pages
MedTech Sales
Compliance, training and interview preparation for medical device sales professionals.
- Pharma vs Device SalesCompare pharma and medical device sales: buyers, sales cycle, product knowledge, compliance codes and the skills phar...
- Sales Compliance (AdvaMed Code)US compliance for device sales reps: Anti-Kickback Statute, Open Payments, AdvaMed Code, off-label rules and complain...
- MedTech Sales TrainingMedTech sales training for pharma reps: eight modules on regulation, compliance, procedures, hospital buying and reim...
- Device Sales Interview Q&ADevice sales interview questions and model answers for pharma reps, with case studies on compliance dilemmas, off-lab...
17 pages
RAC (Devices)
Exam format, strategy, study plans, mock exams and study material for RAC (Devices).
- RAC Master Handbook (2nd Ed.)331-page RAC (Devices) Master Handbook organised by exam domain, with 900+ practice questions and mini-mocks. Covers...
- Handbook Second Edition 2026The 2026 Second Edition RAC (Devices) handbook: 331 pages aligned to the 120-question exam, with practice questions a...
- RAC Practice Test1,000 exam-style RAC (Devices) practice questions with explanations across Recall, Application and Analysis levels. O...
- RAC Practice QuestionsPractise RAC (Devices) exam-style questions across Recall, Application and Analysis levels, with explanations for eve...
- RAC Study Tips (2026)Practical RAC (Devices) study tips for 2026: how to plan by exam domain, use practice questions, review mistakes and...
- RAC Certification GuideYour guide to the RAC (Devices) certification: what it is, how the exam is structured, who it suits and how to prepar...
- What Is RAC (Devices)?What is the RAC (Devices) certification? A plain-English overview of the RAPS credential for medical device regulator...
- Exam Format & StrategyHow the RAC (Devices) exam works: 120 multiple-choice questions in 2.5 hours, the four weighted domains, and a strate...
- How to Answer RAC QuestionsTechniques for scenario-based RAC (Devices) questions: read the stem, eliminate distractors and choose the best answe...
- FDA vs EU MDR for RACKey differences between FDA and EU MDR requirements that RAC (Devices) candidates must know: pathways, classification...
- RAC (Devices) Study MaterialComplete RAC (Devices) exam prep: the 331-page Master Handbook (2nd Ed.) and a 1,000-question practice test bank. Ins...
- Free RAC Mock ExamTake a free full-length RAC (Devices) mock exam: 120 questions in 150 minutes, weighted to the RAPS outline, with ins...
- RAC Mock Exam GuideWhat a RAC (Devices) mock exam is, when to take one and how to review it. Includes a free 120-question, 150-minute mo...
- Reading Your Mock ScoreHow to read a RAC (Devices) mock exam score: score bands, domain breakdown, reviewing wrong answers and turning resul...
- Exam Time ManagementPace the RAC (Devices) exam: 120 questions in 150 minutes. Checkpoints, a two-pass strategy and timed mock practice y...
- 4-Week Mock Exam Study PlanA 4-week RAC (Devices) study plan built around three full mock exams: diagnose, fix weak domains, rehearse and rest....
- RAC Training vs Self-StudySelf-study, structured study material and live training programmes for the RAC (Devices) exam compared, with a practi...
12 pages
Courses
Instructor-led and self-paced programmes for regulatory, quality, software and clinical roles.
- All Medical Device CoursesBrowse AptSkill MedTech courses covering regulatory affairs, software as a medical device, quality systems, clinical...
- SaMD TrainingSoftware as a Medical Device (SaMD) training for regulatory, quality and software teams: qualification, classificatio...
- SaMD MasterclassThe SaMD Masterclass from AptSkill MedTech: a deep dive into regulating software as a medical device, from qualificat...
- SaMD Regulatory Template PackageA complete SaMD regulatory template package from AptSkill MedTech to speed up documentation for software as a medical...
- RA Certificate CourseBuild a career in medical device regulatory affairs with the AptSkill RA Certificate Course: global requirements, sub...
- Advanced QMS CourseAdvanced QMS course for medical device professionals: build, run and improve a quality management system that stands...
- Quality SystemsQuality systems training from AptSkill MedTech: core QMS concepts, documentation and compliance practices for medical...
- Medical Affairs CourseMedical affairs course from AptSkill MedTech for life-science professionals: roles, scientific engagement, evidence g...
- Steps to Access the Medical Affairs CourseStep-by-step instructions to enrol in and access the AptSkill Medical Affairs course, with help from the team if you...
- Clinical Data Management CourseClinical data management course covering the CDM lifecycle, data standards and quality, designed for people starting...
- CDM & Pharmacovigilance CourseCombined clinical data management and pharmacovigilance course from AptSkill MedTech, covering data handling and drug...
- Pharmacovigilance CoursePharmacovigilance course from AptSkill MedTech: drug safety fundamentals, case processing, reporting and a pathway in...