Software as a Medical Device (SaMD) and AI/ML Device Regulation Corporate Training
Navigate SaMD and AI/ML device regulation with confidence across major markets.
Edstellar, a corporate training company, delivers instructor-led SaMD and AI/ML device regulation training that takes cross-functional teams from regulatory uncertainty to a working submission strategy.
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 regulatory-ready SaMD team
THE EDSTELLAR SAMD REGULATORY CAPABILITY MODEL
Diagnose regulatory gaps
Assessments map your product, documentation, and quality system against SaMD expectations.
Standardize the strategy
Teams align on classification, pathway selection, and evidence plans before writing begins.
Practice in guided labs
Teams draft classification rationales, change plans, and documentation with expert review.
Measure submission readiness
Checklists and gap reviews track readiness across technical files and quality systems.
Scale across the portfolio
Templates and change-control rhythms extend the approach to every SaMD product you ship.
Need more than one program?Get a group quote
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Program Overview: What is Software as a Medical Device (SaMD) and AI/ML Device Regulation?
Software as a Medical Device (SaMD) & AI/ML Device Regulation is Edstellar's instructor-led program for cross-functional device teams bringing SaMD and AI/ML products to market. Participants cover the SaMD regulatory landscape, US FDA pathways, EU MDR and clinical evaluation, AI/ML controls on data and bias, technical documentation, and post-market surveillance. It closes with a capstone: a SaMD regulatory strategy dossier.
Training is case-driven across all 24 hours, built around the submissions regulators actually review. Teams map products to risk categories, trace FDA pathways, draft change plans, design AI/ML controls for data and transparency, and assemble technical documentation in guided workshops. Instructors review every artifact with direct feedback, challenging the team's regulatory reasoning the way a reviewer would. The 5-hour capstone produces a complete regulatory strategy dossier for a realistic device.
SaMD programs often discover regulation late: products engineered without a pathway, controls bolted on after design freeze, and documentation assembled under pressure. The program teaches teams to design for clearance from the start: correct categorization, the right pathway, controls for bias and transparency, and a coherent documentation story. Everything is drafted in workshops, so the discipline becomes habit.
The regulatory strategy dossier is the document that decides whether a device moves or stalls, and the capstone treats it that way. The team writes a full dossier for a realistic SaMD product: risk categorization, pathway rationale, FDA and EU strategy, AI/ML control design, and a post-market plan, all defended in review. What the team takes back is a submission it has already stress-tested, and the judgment to build the next one faster.
Six modules and 24 hours: the SaMD regulatory landscape, US FDA pathways and predetermined change control plans, EU MDR and clinical evaluation, AI/ML-specific controls, technical documentation and post-market duties, and a capstone where each team assembles a regulatory strategy dossier. Every module pairs concept delivery with hands-on labs so teams leave with draft rationales, plans, and checklists, not just theory.
What's Included in this Workshop for Your Enterprise Teams
- 1
Classification workshop
Apply the IMDRF risk framework to categorize your SaMD product.
- 2
Pathway selection lab
Compare FDA pathways and document your rationale with expert feedback.
- 3
Change plan drafting
Draft a predetermined change control plan for an AI/ML update.
- 4
Documentation sprint
Build technical file sections with guided templates and review.
- 5
Dossier presentation
Present your regulatory strategy dossier for peer and expert review.
- Live instructor-led sessions, delivered hybrid, onsite, or virtual
- Guided documentation labs with expert review and feedback
- Templates: classification rationales, change plans, checklists
- Submission-readiness gap review for your product
- Course materials and lab guides shared on your LMS
- Completion summary with readiness findings
Build your team's skills. Anywhere in the world.
Real-world use cases
from day one
Instructor-led training
for your teams
Delivered globally
in 100+ countries
Enterprise Training Solutions Customized for Your Company
One partner for instructor-led corporate training, delivered the way your teams work.
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Software as a Medical Device (SaMD) and AI/ML Device Regulation Course Topics and Program Outline
A tailored 24-hour, six-module workshop: one learning journey from SaMD foundations to a working regulatory strategy dossier.
Built by Edstellar with regulatory affairs practitioners
Built by regulatory practitioners who have prepared SaMD submissions for major markets, shaped around your product and portfolio.
Gap reviews baseline your product, documentation, and quality system against current SaMD expectations.
Foundations cover SaMD definitions, IMDRF risk categorization, FDA pathways, and EU MDR requirements.
Guided labs have teams drafting classification rationales, change plans, and documentation with expert review.
Teams assemble technical files, surveillance plans, and a regulatory strategy dossier for their product.
From risk categorization to a regulatory strategy dossier, every lab moves your product toward submission.
Delivered as
Delivered as a hybrid program of live instruction and guided labs, scheduled around your team calendar in flexible batches.
Categorize three sample SaMD products using the IMDRF framework with expert review.
learna)SaMD definitions and scope boundaries
b)IMDRF risk categorization framework
c)US, EU, and UK regulatory overview
d)Classification exercises on real products
Draft a pathway selection rationale for a sample AI/ML device with coaching.
learna)510(k) substantial equivalence basics
b)De Novo pathway and when it applies
c)Predetermined change control plans
d)FDA AI/ML guidance landscape
Map your product to MDR rules and outline a clinical evaluation plan in a guided lab.
practicea)EU MDR classification rules for software
b)Clinical evaluation and evidence planning
c)Quality management system essentials
d)Technical documentation structure
Draft a bias evaluation and transparency plan for a sample ML diagnostic aid.
practicea)Training data quality and representativeness
b)Bias evaluation and mitigation
c)Transparency and labeling for AI/ML
d)Human oversight and risk controls
Build technical file sections and a surveillance plan using guided templates.
applya)Technical file content and structure
b)Labeling and instructions for use
c)Post-market surveillance planning
d)Vigilance, recalls, and field updates
Deliver your complete regulatory strategy dossier in a final expert review.
applya)Product and intended-use definition
b)Classification and pathway strategy
c)Evidence and documentation roadmap
d)Dossier presentation and expert review
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 job-ready outcomes your team will demonstrate by the end of the program. Each competency is practiced in guided labs.
Classify SaMD under IMDRF frameworks
Apply risk categorization to determine your product’s regulatory obligations.
Select the right FDA pathway
Compare 510(k), De Novo, and exemption routes and document the rationale.
Plan EU MDR compliance
Map classification rules, clinical evaluation, and QMS needs for European markets.
Draft AI/ML change control plans
Write predetermined change control plans that let models evolve compliantly.
Address AI/ML-specific controls
Plan for data quality, bias evaluation, transparency, and human oversight.
Build submission documentation
Assemble technical files, labeling, and evidence plans reviewers expect.
Run post-market surveillance
Plan vigilance, updates, and field actions across the product lifecycle.
Teams that Benefit from this Software as a Medical Device (SaMD) and AI/ML Device Regulation Group Training
This group training is built for cross-functional device teams bringing SaMD and AI/ML products to market. Content adapts to each cohort’s products, target markets, and quality system so every team practices the workflows it owns.
Own the SaMD submission strategy end to end.
Regulatory professionals learn pathway selection, change planning, and dossier assembly for SaMD and AI/ML.
Workflow friction
- Uncertain AI/ML expectations
- Evolving guidance documents
- Multi-market complexity
How the program helps
- Clear pathway selection rationale
- Faster dossier preparation
- Defensible change plans
Practice use cases
- pathway selection
- change plans
- dossier assembly
Align the QMS with SaMD expectations.
QA teams learn software lifecycle controls, documentation practices, and audit readiness for SaMD.
Workflow friction
- Software-specific QMS gaps
- Documentation inconsistencies
- Audit findings on software
How the program helps
- Audit-ready documentation
- Stronger design controls
- Clearer CAPA linkages
Practice use cases
- design controls
- documentation
- audit readiness
Build SaMD that survives regulatory review.
Engineers learn what regulators expect from data, algorithms, testing, and change management.
Workflow friction
- Regulatory blind spots in code
- Weak ML validation practices
- Uncontrolled model updates
How the program helps
- Review-ready development artifacts
- Fewer late-stage rework cycles
- Clearer requirements traceability
Practice use cases
- validation
- traceability
- model updates
Plan clinical evidence that satisfies reviewers.
Clinical teams learn evaluation planning, real-world evidence use, and post-market study design.
Workflow friction
- Evidence gaps at submission
- Costly late-stage studies
- Weak post-market data
How the program helps
- Stronger evidence packages
- Better study designs
- Clearer benefit-risk stories
Practice use cases
- evidence planning
- study design
- post-market data
Cohorts train as a cross-functional product team, with each small group aligned on shared regulatory strategy and documentation standards.
Prerequisites: This program benefits regulatory, quality, clinical, and software professionals working on SaMD or AI/ML devices. Basic familiarity with medical device regulation helps but is not required. Content adapts to each cohort’s products, target markets, and quality system.
Associate to SaMD Regulatory Lead
Tracks how professionals progress from basic SaMD concepts to advanced strategy and dossier leadership.
A program that grows with regulatory careers, from first SaMD classification to leading multi-market submissions.
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
Live instruction with guided documentation labs, delivered in the format that fits your team calendar and locations.
Hybrid Training
Instructor-led sessions mix onsite and virtual delivery with guided labs where teams draft regulatory documents.
- Live instruction across onsite and virtual sessions
- Guided labs with expert review and feedback
- Cohorts grouped by product or portfolio
- Recordings and templates on your LMS
Onsite Training
Instructor-led training at your offices, with labs tailored to your products and quality system.
- Instructor-led training at your offices
- Labs tailored to your products
- Cross-functional team exercises
- Leadership readout at close of program
Live Virtual Training
Live virtual sessions with screen-shared document drafting, breakout labs, and same-day expert feedback.
- Live virtual sessions with expert instructors
- Screen-shared drafting and breakout labs
- Same-day feedback on documents
- Flexible batches across time zones
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, products, target markets, and delivery preference for a tailored proposal within two business days.
Yes. A short call aligns the program to your products, markets, and submission goals before we finalize.
Yes. Live virtual batches run across time zones with the same labs and expert feedback as onsite.
Yes. Onsite delivery includes labs tailored to your products, plus a leadership readout at close.
The program runs 24 hours across six modules, typically delivered over three to four weeks in flexible batches.
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.
AI and machine learning devices still need a quality system and a compliant software life cycle before the AI-specific rules apply. Your team builds the QMS, meets IEC 62304, then handles AI device regulation, and finally sets up clinical governance for AI in use.
Why Choose Edstellar as Your Corporate Training Provider for Software as a Medical Device (SaMD) and AI/ML Device Regulation Course
When comparing providers, Edstellar is the training partner teams choose for regulatory expertise and 5+ years of corporate training delivery.
EXPERT TRAINERS
YEARS DELIVERING
ORGANIZATIONS TRAINED
CERTIFIED
Tailored
Every cohort's labs and templates are tuned to your SaMD products and target markets, so teams draft real documents.
Proven Methodology
A practitioner-built curriculum covering FDA pathways, EU MDR, and IMDRF frameworks used by device teams worldwide.
Practice-Based Learning
Teams draft classification rationales and change plans in guided labs, with expert review the same day.
Expert Trainers
Instructors are regulatory practitioners experienced with SaMD submissions in major markets.
Global Scale
One consistent program delivered across regions and time zones, scheduled around your team calendar.
Measurable Outcomes
Track submission readiness with gap reviews and checklists, so leaders see progress toward filing.
Build SaMD Regulatory Strategies With Clear Evidence and AI Controls
Edstellar connects medical-software regulatory strategy with the documentation needed to explain product decisions. Participants examine classification, pathway options, clinical and quality considerations, and AI-specific controls using sample devices. A strategy dossier is reviewed for traceable rationale, coherent evidence plans, and explicit treatment of change and surveillance needs.
- Step 01
Consult
We discuss regulatory, quality, clinical, and software responsibilities to identify gaps in SaMD categorization, pathway reasoning, AI controls, and technical-documentation planning.
- Step 02
Plan
Regulatory and risk foundations lead into FDA pathways, EU requirements, AI data and bias controls, and surveillance before an integrated strategy dossier.
- Step 03
Align
Medical-device regulatory and quality expertise supports cross-functional teams, aligning explanations with their existing knowledge and responsibility for product evidence and software changes.
- Step 04
Customize
Fictional SaMD and AI-device profiles create realistic classification and documentation exercises without using patient records or implying approval of an actual medical product.
- Step 05
Execute
Participants justify pathway choices, draft technical-file sections, and build surveillance plans, receiving feedback on evidence gaps, AI-control reasoning, and documentation consistency.
- Step 06
Evaluate
We assess the dossier for supported classification and pathway rationale, coherent evidence plans, explicit AI risks, and clearly documented change and surveillance responsibilities.
Also from Edstellar
Talent assessments
Psychometric, behavioral, leadership and 360-degree assessment.
→Training needs analysis
Needs analysis, gap identification, and a training roadmap.
→L&D consulting
Learning strategy, content, technology and ROI measurement.
→OD consulting
Org design, succession planning and cultural change.
→Managed training services
Training outsourcing, vendor management, logistics and administration.
→Coaching solutions
Executive and manager coaching that keeps skills in use.
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) & AI/ML Device Regulation 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 AI/ML Device Regulation Training for Your Team
Share your team size, products, target markets, and timelines to receive a tailored training plan and group quote.