Software as a Medical Device (SaMD) and IEC 62304 Corporate Training
Ship compliant medical device software with practiced IEC 62304 processes, in live instructor-led labs built around real SaMD scenarios.
Edstellar, a corporate training company, delivers corporate training that helps your team master SaMD development under IEC 62304. Employees classify software safety, write traceable requirements, and build verification evidence through guided labs led by medical device practitioners. Each session is tuned to your product, quality system, and target markets.
Instructor-led group trainingVirtual / on-site / off-site10 languagesDelivered inEnglish, Spanish, Mandarin, German, Arabic, Portuguese, Hindi, French, Japanese, Italian100+ countriesWe have delivered inUnited States, United Kingdom, India, Canada, Germany, France, Netherlands, UAE, Saudi Arabia, Singapore, Australia, Japan, Brazil, South Africa and 90+ more countries
How we build a audit-ready SaMD team
The Edstellar SAMD Capability Model
Diagnose
We review your SaMD portfolio, software safety classifications, and current 62304 practices to focus the program where compliance risk is highest.
Standardize
Teams agree on lifecycle conventions, documentation depth, and traceability practice so every release follows the same compliant path.
Practice
Learners classify safety, write requirements, and build verification evidence in guided labs, with an instructor coaching every work product.
Measure
Instructors assess each team’s requirements, trace matrices, and risk files against clear, measured criteria for audit readiness.
Scale
Your team leaves with reusable lifecycle templates and checklists they can roll out to every SaMD product and release.
Need more than one program?Get a group quote
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Program Overview: What is Software as a Medical Device (SaMD) and IEC 62304?
Software as a Medical Device (SaMD) & IEC 62304 is Edstellar's instructor-led technical program for the teams that ship regulated software: engineering, quality, regulatory, and product. Participants work through the IEC 62304 lifecycle, software safety classification, requirements and risk management, architecture and design, verification, and SOUP management. It closes with a capstone: a SaMD IEC 62304 compliance file.
Training is hands-on across all 28 hours, with the team working a realistic device through the full lifecycle in guided labs. Engineers classify software safety, write requirements, manage risks, design and verify units, integrate and test the system, and manage SOUP items in supervised sessions. Instructors review every work product with direct feedback, checking traceability and rigor the way an auditor would. The 6-hour capstone assembles a complete compliance file the team defends in review.
Regulated software fails audits on traceability, not effort: requirements nobody can trace, risks documented after the fact, and SOUP nobody evaluated. The program teaches the IEC 62304 discipline as a working habit: classify early, write requirements that trace, verify at every level, and keep the file audit-ready. Each work product is built in labs, so rigor survives real deadlines.
An auditor does not grade intentions; the auditor grades the file. The capstone has the team produce one: a compliance file with safety classification, traced requirements, risk management records, verification evidence, and SOUP evaluations, reviewed as if the audit were real. The team leaves having built the artifact that protects every release, and the working knowledge to keep it current as the software evolves.
The program moves from SaMD regulatory foundations into intensive, hands-on lifecycle work. Your team learns to scope safety classes, write testable requirements, design verifiable architectures, control SOUP, and maintain software after release. By the final capstone, participants deliver an IEC 62304 compliance file for a SaMD product, complete with traceability and risk evidence.
What's Included in this Workshop for Your Enterprise Teams
- 1
SaMD regulation
IMDRF framework, FDA pathways, and SaMD risk categorization.
- 2
IEC 62304 lifecycle
Lifecycle processes and software safety classes A, B, C.
- 3
Requirements and risk
Testable requirements, traceability, and ISO 14971 risk files.
- 4
Design and verification
Architecture, unit verification, and interface control.
- 5
SOUP and system testing
SOUP evaluation, integration testing, and trace matrices.
- 6
Capstone compliance file
An audit-ready IEC 62304 file for a SaMD product.
- Instructor-led delivery across virtual, onsite, and hybrid
- Guided labs in every module with instructor coaching
- Capstone compliance file, reviewed with your team
- Flexible scheduling around your calendar
- Lifecycle templates and traceability guides included
- Group size and batches set along with you
Build your team's skills. Anywhere in the world.
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Delivered globally
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Software as a Medical Device (SaMD) and IEC 62304 Course Topics and Program Outline
Seven instructor-led modules take your team from SaMD regulatory foundations to an audit-ready IEC 62304 compliance file for a real product.
Built by Edstellar with medical device software and quality professionals who ship regulated SaMD products
Built by practitioners who develop SaMD under IEC 62304 and defend lifecycle evidence in audits, shaped around your stack and use cases.
We review your SaMD portfolio, safety classes, and current lifecycle practices to focus every lab on your highest compliance risks.
Instructor-led sessions teach SaMD regulation, IEC 62304 processes, and safety classification with live documentation walkthroughs.
Teams write requirements, run risk analyses, and build verification evidence in guided labs, with coaching on every work product.
Your team delivers an audit-ready IEC 62304 compliance file for a real SaMD product in the capstone.
Every template and trace matrix targets your own products, so audit readiness improves before the program ends.
Delivered as
Instructor-led over 28 hours with guided labs in every module and a capstone compliance file reviewed with your team.
Intro lab: map your product portfolio to SaMD categories and identify the regulatory pathway for each product.
learna)What qualifies as SaMD under the IMDRF framework
b)FDA, EU MDR, and global SaMD pathways
c)SaMD risk categorization and its documentation impact
d)Intended use and claims discipline
e)Quality system expectations for SaMD teams
Intro lab: classify software items for a SaMD product and scope the 62304 processes each class requires.
learna)IEC 62304 processes and the lifecycle model
b)Software safety classes A, B, and C
c)Class-driven process rigor and documentation depth
d)Legacy software and gap analysis
e)Tool qualification basics for development tools
Practice lab: author a software requirements set with traceability and a linked hazard analysis.
practicea)Writing testable software requirements
b)Traceability from system to software requirements
c)ISO 14971 risk management applied to software
d)Hazard analysis and software risk controls
e)SOUP risk considerations in requirements
Practice lab: review an architecture for safety segregation and write a unit verification plan.
practicea)Software architecture for safety-critical functions
b)Detailed design and interface control
c)Unit verification strategies and coverage
d)Code review and static analysis practice
e)Segregation and defensive design patterns
Practice lab: build a verification protocol with trace matrix and evaluate a SOUP candidate.
practicea)Integration planning and interface testing
b)System-level verification protocols
c)SOUP evaluation and anomaly list maintenance
d)Regression strategy across releases
e)Test evidence and trace matrices
Practice lab: run a change impact analysis and draft a problem resolution record.
applya)Release readiness and version control discipline
b)Problem resolution and change control
c)Post-market surveillance data loops for software
d)Cybersecurity maintenance for SaMD
e)Documentation packages for audits and submissions
Capstone lab: produce the compliance file for a SaMD product, reviewed with your team.
applya)Assembled lifecycle documentation set
b)Traceability matrix review end to end
c)Risk file and safety case summary
d)Audit-readiness walkthrough with the instructor
e)Sign-off and gap remediation plan
Customize this program tailored to your team?
Tell us your training needs: what your team already works with, the level they’re at, and the topics you want them to focus on. We’ll adjust the modules, duration and hands-on labs, and send you a customized outline for your group.
Key Skills and Outcomes Your Team Will Gain
Seven outcome areas your team practices in guided labs, from safety classification to audit-ready verification evidence.
Classify SaMD software safety
Apply IEC 62304 software safety classes A, B, and C to product functions and scope the right process rigor.
Write traceable requirements
Author testable software requirements with bidirectional traceability from system level down.
Manage software risk
Run ISO 14971 hazard analysis for software and define risk controls your team can defend.
Design verifiable architecture
Structure software architecture with segregation and interfaces that make verification practical.
Control SOUP
Evaluate software of unknown provenance, maintain anomaly lists, and plan SOUP maintenance safely.
Build verification evidence
Plan integration and system verification with protocols and trace matrices that satisfy auditors.
Maintain released SaMD
Run problem resolution, change control, and post-market surveillance for software after release.
Teams that Benefit from this Software as a Medical Device (SaMD) and IEC 62304 Group Training
Built for the teams that ship regulated software: engineering, quality, regulatory, and product. The content adapts to role and experience, so each cohort practices the lifecycle workflows it owns for its own products.
Own the 62304 compliance file
Your regulatory and quality professionals build the lifecycle evidence that passes audits and submissions.
Workflow friction
- Evidence scattered across tools
- Traceability breaks at release
- Audit findings repeat
How the program helps
- Traceability your team defends
- Risk files auditors accept
- Release records done right
Practice use cases
- Trace matrix labs
- Risk file workshops
- Audit readiness reviews
Build safety into the code
Engineering teams practice safety classification, defensive design, and verification that scales with the product.
Workflow friction
- Requirements untestable
- Unit tests miss safety paths
- SOUP updates surprise teams
How the program helps
- Safety classes scoped correctly
- Verification planned with design
- SOUP handled systematically
Practice use cases
- Requirements authoring labs
- Design review practice
- SOUP evaluation drills
Scope SaMD claims safely
Product teams learn intended-use discipline and change impact analysis for regulated software.
Workflow friction
- Feature creep breaks safety case
- Claims outrun verification
- Release pressure skips steps
How the program helps
- Claims matched to evidence
- Change impact assessed early
- Roadmaps respect release gates
Practice use cases
- Intended-use workshops
- Change impact labs
- Release gate reviews
Close the post-market loop
Clinical and support teams feed field data into problem resolution and surveillance practice.
Workflow friction
- Field data never reaches R&D
- Complaints lack software context
- Surveillance is reactive
How the program helps
- Complaints feed risk files
- Field signals triaged fast
- Support data strengthens files
Practice use cases
- Complaint triage labs
- Surveillance planning
- Feedback loop design
Cohorts are shaped around your SaMD products, so each team practices on scenarios from its own portfolio.
Prerequisites: Software professionals, quality and regulatory staff, and product managers involved in medical device software benefit most. Familiarity with software development and basic quality concepts helps, but the program starts from lifecycle foundations and adapts labs to your team's tools, products, and target markets.
Software engineer to SaMD lifecycle owner
Progression maps each skill to the module phase where it is taught and the depth your team reaches by the capstone.
A learning path that grows with regulated-software careers, from lifecycle basics to owning a product’s 62304 compliance file.
Mixed cohort, or several teams at once?
We can tailor the training to different teams, roles, and experience levels within the same program.
Certificate of Training Completion.
On successful completion, employees receive an Edstellar course completion certificate, recognizing their commitment to ongoing learning and professional development. It validates the skills they have built and motivates them to keep growing and contribute to organizational success.
Earned, not attended. Awarded on completion of all hands-on labs and the capstone project.
Training Delivery Modes: Virtual, Onsite and Hybrid
Instructor-led sessions with guided labs throughout, delivered your way across onsite, virtual, and hybrid formats.
Hybrid Training
Instructor-led sessions mix onsite and virtual delivery with guided labs throughout. Teams classify safety and build verification evidence while the instructor coaches each work product. Hybrid keeps scheduling flexible without losing live interaction.
- Live instruction across onsite and virtual sessions
- Guided labs with instructor coaching and evidence reviews
- Real SaMD scenarios from your product portfolio
- Capstone compliance file reviewed with your team
Onsite Training
Onsite sessions put the instructor at your facility with your quality system and product examples. Teams practice requirements and risk analysis face to face, working your actual documentation conventions. Onsite keeps the focus on your products.
- Instructor at your facility
- Labs built around your own products
- Face-to-face evidence reviews
- Immediate feedback on lifecycle discipline
Live Virtual Training
Live virtual sessions deliver the same instructor-led labs through interactive online workshops. Teams share screens for trace matrices and risk files while the instructor reviews each work product. Virtual keeps distributed sites in the same room.
- Live online instructor-led labs
- Shared lifecycle and risk templates
- Breakout practice on SaMD scenarios
- Digital capstone review sessions
Need a training format that works for your team?
Full days, half days across weeks, or split by module. Tell us the delivery window and we schedule the cohort around it.
Frequently Asked Questions
Share your team size, product portfolio, and preferred dates through the group quote form, and a training advisor will respond within one business day with pricing.
Yes. A short discovery call with a training advisor aligns the agenda, labs, and capstone product with your SaMD compliance goals.
Yes. The program runs fully live virtual with the same instructor-led labs, or onsite, or as a hybrid mix across your sites.
Yes. Onsite delivery lets the instructor use your quality system, tools, and product examples directly in the labs.
The program runs 28 instructor-led hours, typically scheduled across flexible session blocks that fit your release calendar.
Question not answered here?
Put it in the request. A training specialist answers it directly, within one business day.
Where this Training Fits in Your Team's learning path.
IEC 62304 assumes a working quality system, so the QMS comes first in this path. Once your team can build software to the standard, it moves on to the extra rules for AI and ML devices and to the cybersecurity work that continues after release.
Why Choose Edstellar as Your Software as a Medical Device (SaMD) and IEC 62304 Corporate Training Provider
Edstellar pairs medical device practitioners with your team for instructor-led labs that produce audit-ready lifecycle evidence, shaped around your products and target markets.
EXPERT TRAINERS
YEARS DELIVERING
ORGANIZATIONS TRAINED
CERTIFIED
Tailored
Agendas, labs, and the capstone file are shaped around your SaMD products, safety classes, and target markets.
Proven Methodology
A lifecycle arc that moves from SaMD regulation to classification, requirements, risk, and verification evidence, step by step.
Practice-Based Learning
Every module includes guided labs where teams author requirements and build verification evidence with instructor coaching.
Expert Trainers
Medical device software and quality professionals who ship regulated products and face audits lead your sessions.
Global Scale
Consistent lifecycle standards and delivery quality across every product team, site, and cohort your program reaches.
Measurable Outcomes
Work-product reviews, traceability checks, and a reviewed capstone compliance file prove the readiness your team gained.
Connect IEC 62304 Lifecycle Work With Traceable Medical-Software Evidence
Edstellar develops SaMD lifecycle capability through requirements, risk, design, verification, and maintenance exercises. Teams classify sample software, connect work products, and examine SOUP and change decisions. A compliance-file review tests traceability, supporting evidence, and a clear explanation of how lifecycle activities address the identified software risks.
- Step 01
Consult
We explore software-development experience and quality responsibilities to identify gaps in safety classification, requirements traceability, verification, SOUP control, and maintenance records.
- Step 02
Plan
SaMD foundations lead into IEC 62304 processes, risk and requirements, architecture, verification, and integration before release, maintenance, and a complete lifecycle file.
- Step 03
Align
Medical-software lifecycle and quality expertise supports engineering, regulatory, and product roles, connecting process obligations with the technical work and evidence each function owns.
- Step 04
Customize
A fictional SaMD product and sample software items provide realistic safety and change cases without using patient data or assessing a live clinical deployment.
- Step 05
Execute
Participants classify software, connect requirements to tests, and analyze change impacts, receiving feedback on risk links, SOUP decisions, and problem-resolution documentation.
- Step 06
Evaluate
We assess the compliance file for consistent classification, traceable requirements and verification, documented SOUP controls, and supported release or maintenance decisions.
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Start an RFP shaped to your needs.
Answer three quick questions about team size, scope, and how often you need the program run, then send the request from the last step. Everything you choose travels with it, so you only fill this in once.
How many team members need training?
Software as a Medical Device (SaMD) & IEC 62304 Training Packages & Pricing
Where L&D holds an annual budget, license packages price the whole year at once instead of raising a purchase order per workshop. Hours and licenses are pooled across teams, programs and locations, so unused capacity is not stranded in one department.
Starter
120
trainee licenses64 hours of group training
Tailored for SMBs
Growth
320
trainee licenses160 hours of group training
Ideal for growing SMBs
Enterprise
800
trainee licenses400 hours of group training
Designed for large corporations
Custom
Unlimited
trainee licensesDuration set by the rollout
Multi-region and multi-year
Training Packages & Pricing
Choose the training format that works for your team. Pricing is customized based on your requirements, cohort size, and delivery needs.
Request Software as a Medical Device (SaMD) and IEC 62304 Training for Your Team
Tell us about your team, your SaMD products, and the markets you target. A training advisor will shape the agenda, labs, and delivery format around your goals.