A tailored course, built for your situation
Software Safety and Quality Mastery for Medical Devices
A complete guide to risk-based compliance and RA strategy
$199 one-time
24-hour access provisioning
30-day money-back guarantee
Hand-built implementation playbook
12 modules. 12 chapters per module. 144 chapters total.
12 modules, each with 12 chapters (144 chapters total), text-based, plus downloadable templates and a hand-built implementation playbook delivered alongside course access.
Struggling to align your quality systems expertise with medical software compliance demands?
The situation this course is for
You're actively pursuing roles in QM/RA for medical technology, but hiring managers expect proven experience with safety classification, risk management files, and regulatory documentation, all while standards evolve rapidly. Without a structured way to demonstrate mastery, even qualified candidates get overlooked.
Who this is for
A quality or regulatory professional transitioning into or advancing within medical software or biotech, with exposure to safety-critical systems and a need to prove compliance fluency.
Who this is not for
Engineers focused solely on coding, non-regulated software developers, or executives seeking high-level overviews without implementation detail.
What you walk away with
- Master risk-based software classification for medical devices
- Build audit-ready quality documentation from scratch
- Navigate ISO 14971 and IEC 62304 compliance with confidence
- Position yourself as a go-to RA/QM candidate in biotech hiring cycles
- Reduce time-to-hire by demonstrating structured compliance knowledge
The 12 modules (with all 144 chapters)
Module 1. Foundations of Medical Software Safety
Establish core principles of safety-critical software, including definitions, regulatory scope, and the role of risk classification in development lifecycle planning.
12 chapters in this module
- What is safety-critical software
- Regulatory vs commercial software
- Overview of medical device sectors
- Role of software in devices
- Classification by impact level
- Risk-based development approach
- Regulatory expectations baseline
- FDA and EU MDR alignment
- Quality systems integration
- Documentation hierarchy
- Lifecycle phase mapping
- Compliance mindset shift
Module 2. Risk Management Frameworks
Apply ISO 14971 principles to software risk analysis, hazard identification, and risk control strategies specific to medical applications.
12 chapters in this module
- ISO 14971 fundamentals
- Hazard identification process
- Use of FMEA in software
- Risk acceptability criteria
- Residual risk evaluation
- Risk control hierarchy
- Software-specific hazards
- Hazard traceability matrix
- Risk documentation structure
- Integration with design inputs
- Risk review cadence
- Audit preparation for risk files
Module 3. Software Safety Classification
Classify software components using IEC 62304 rules, determine class based on patient impact, and justify classification in documentation.
12 chapters in this module
- IEC 62304 overview
- Software safety classes
- Determining classification basis
- Class A vs B vs C
- Impact on development rigor
- Justification documentation
- Change-driven reclassification
- Integration with system risk
- Software of unknown pedigree
- Third-party component handling
- Classification review process
- Regulatory inspection readiness
Module 4. Regulatory Pathways and Submissions
Navigate FDA 510(k), De Novo, and EU MDR technical documentation requirements for software components.
12 chapters in this module
- FDA submission types
- 510(k) vs De Novo path
- Technical file structure
- EU MDR compliance steps
- Software description content
- Verification validation planning
- Cybersecurity documentation
- Clinical evaluation linkage
- Post-market requirements
- Notified body interaction
- Submission timeline planning
- Common deficiencies to avoid
Module 5. Quality Management System Design
Build a compliant QMS tailored to software development, including SOPs, document control, and change management workflows.
12 chapters in this module
- QMS for software teams
- Document control systems
- SOP development process
- Change control procedures
- Versioning and traceability
- Configuration management
- Deviation handling
- Training requirements
- Internal audit planning
- Management review inputs
- CAPA integration
- QMS scalability
Module 6. Verification and Validation Strategy
Develop test plans, traceability matrices, and validation protocols that meet regulatory scrutiny for safety-classified software.
12 chapters in this module
- V&V planning basics
- Test strategy alignment
- Traceability matrix creation
- Unit integration system testing
- Automated testing compliance
- Validation protocol structure
- User scenario testing
- Defect tracking process
- Test environment controls
- Regression testing cycles
- Validation report writing
- Audit trail maintenance
Module 7. Cybersecurity and Data Integrity
Implement controls for data protection, authentication, and secure software updates in compliance with FDA cybersecurity guidance.
12 chapters in this module
- Medical device cybersecurity
- Threat modeling basics
- Authentication mechanisms
- Data encryption standards
- Secure update processes
- Penetration testing role
- Vulnerability disclosure
- Patch management
- Data integrity controls
- Audit logging
- Third-party risk
- Regulatory expectations
Module 8. Design Controls and Traceability
Apply design controls from concept to release, ensuring full traceability from requirements to testing outcomes.
12 chapters in this module
- Design control lifecycle
- Design inputs definition
- Design output mapping
- Traceability matrix use
- Design review process
- Design verification steps
- Design validation planning
- Design transfer process
- Design change control
- Design history file
- Tool qualification
- Regulatory inspection prep
Module 9. Post-Market Surveillance and Reporting
Establish systems for monitoring field performance, managing complaints, and meeting MDR and FDA post-market obligations.
12 chapters in this module
- Post-market surveillance
- Complaint handling process
- Adverse event reporting
- Field action management
- Trend analysis
- Periodic safety updates
- CAPA linkage
- Software update compliance
- User feedback loops
- Vigilance reporting
- Regulatory timelines
- Documentation retention
Module 10. Audit Preparation and Inspection Readiness
Prepare for internal, notified body, and regulatory audits with documentation, training, and response strategies.
12 chapters in this module
- Audit types overview
- Internal audit planning
- Notified body prep
- FDA inspection readiness
- Document retrieval
- Audit response protocol
- Common findings list
- Corrective action planning
- Audit trail review
- Personnel training
- Mock audit execution
- Follow-up tracking
Module 11. Global Regulatory Alignment
Compare FDA, EU MDR, Health Canada, and other regional requirements for software in medical devices.
12 chapters in this module
- FDA vs EU MDR
- Health Canada approach
- Japan PMDA process
- China NMPA basics
- Global submission strategy
- Regional variation handling
- Language requirements
- Local representative role
- Harmonization efforts
- Standards adoption
- Country-specific gaps
- Market prioritization
Module 12. Career Advancement in QM/RA
Position yourself effectively for QM/RA roles with targeted resumes, interview strategies, and compliance storytelling.
12 chapters in this module
- RA career pathways
- Resume optimization
- LinkedIn profile tuning
- Networking in med device
- Interview question prep
- Compliance storytelling
- Certification value
- Continuous learning
- Mentorship sourcing
- Job board targeting
- Negotiation tactics
- Growth planning
How this maps to your situation
- You're transitioning into medical software QM/RA and need structured knowledge.
- You're preparing for audits or job interviews in regulated environments.
- You're building or improving a quality system for software compliance.
- You're seeking clarity on how safety classification drives development rigor.
Before vs. after
Before
Uncertain how to structure compliance work or demonstrate mastery in safety-critical software roles.
After
Confidently navigate regulatory expectations, build audit-ready files, and position yourself as a top candidate in QM/RA hiring.
What's included with your purchase
- 12 modules with 12 chapters each (144 chapters)
- Downloadable templates and worked examples for every module
- Hand-built implementation playbook delivered alongside course access
- 30-day money-back guarantee
Delivery and format
- Course and learning environment access provisioned within 24 hours of purchase
- Hand-built implementation playbook delivered alongside course access
Format: Text-based modules and chapters in the Art of Service learning environment, plus downloadable templates and worked examples for every chapter, plus the hand-built implementation playbook delivered alongside course access.
Time investment: Approximately 3-4 hours per module, designed for flexible, self-paced learning alongside professional commitments.
If nothing changes
Without structured compliance knowledge, even experienced professionals miss opportunities due to inability to demonstrate regulatory fluency during hiring cycles or audits.
How this compares to the alternatives
Unlike generic compliance courses, this program focuses exclusively on medical software safety and RA strategy, with templates and examples tailored to real-world hiring and audit scenarios, no fluff, only actionable frameworks.
Frequently asked
Who is this course for?
Quality and regulatory professionals targeting roles in medical software or biotech with a need to demonstrate compliance mastery.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Does it include templates?
Yes, every module includes downloadable templates and worked examples for immediate application.
$199 one-time. Approximately 3-4 hours per module, designed for flexible, self-paced learning alongside professional commitments..
Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.
30-day money-back guarantee·
144 chapters·
Hand-built playbook included·
Account access within 24 hours