Software as a Medical Device Training Course
Build practical SaMD regulatory knowledge with expert-led training designed for software medical device teams. Learn how classification, IEC 62304, ISO 14971, quality systems, and global submission expectations fit together so your team can make better development, documentation, and compliance decisions with confidence.
Our Software as a Medical Device Training Course Services
Focused training and advisory support for SaMD teams building regulatory knowledge and submission readiness.
SaMD Training
Structured training for software medical device teams covering classification, regulatory pathways, documentation expectations, and core compliance principles needed to support safer development and stronger submissions.
SaMD Consulting
Expert guidance for Software as a Medical Device programs, including classification support, pathway determination, and jurisdiction-specific compliance planning across major regulatory markets.
Submission Readiness
Readiness assessments that evaluate documentation, risk management, quality alignment, and evidence gaps before your team moves toward regulatory submission or authority engagement.
Global Strategy
Training-informed regulatory strategy support for teams preparing software medical devices for FDA, EU, TGA, Health Canada, and other international pathways.
Pre-Submission Support
Preparation support for teams planning pre-sub meetings, pathway discussions, and submission strategy decisions before formal regulatory filing begins.
Compliance Assessment
Detailed compliance reviews that identify documentation weaknesses, regulatory gaps, and remediation priorities for SaMD products and supporting quality systems.
Practical Regulatory Learning
Turn SaMD Complexity Into Team Confidence
A strong Software as a Medical Device Training Course helps teams connect software development decisions with real regulatory expectations. Elexes delivers practical instruction grounded in SaMD classification, software lifecycle controls, risk management, quality systems, and submission strategy so product, quality, and regulatory teams can work from the same compliance playbook.
Trusted By Manufacturers
Success Stories
See how regulated product teams strengthen readiness, documentation, and compliance through expert support.
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.”
Samip Shah
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing.”
Daniel Kinsey
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.”
Elizabeth W
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.”
Samip Shah
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing.”
Daniel Kinsey
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.”
Elizabeth W
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.”
Samip Shah
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing.”
Daniel Kinsey
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.”
Elizabeth W
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
The Elexes Difference
Why Choose Elexes?
Elexes combines deep regulatory expertise with practical training that teams can apply immediately.
Deep Expertise
50+ years of collective experience across SaMD, FDA, ISO, EU MDR, and global frameworks.
End-to-End Support
Training is backed by real-world support from development through approvals and post-market obligations.
Proven Results
250+ successful projects and a 90% audit clearance rate reinforce practical, defensible guidance.
Flexible Delivery
Choose project-based, part-time, or embedded support models that fit your internal team structure.
Meet The Elexes Team
Experienced specialists in medical device compliance and training.
Elexes is a trusted medical device regulatory consulting partner serving manufacturers, digital health companies, and SaMD developers across global markets. The company has built its reputation by helping organizations navigate regulatory approvals, due diligence, quality system support, and post-market obligations with clarity and discipline. Backed by 50+ years of collective experience, the Elexes team brings practical expertise across FDA, EU MDR, Health Canada, TGA, ISO 13485, ISO 14971, and IEC 62304 expectations. That depth makes its training especially valuable for software teams that need more than theory. Elexes focuses on turning complex regulatory requirements into usable knowledge that supports better documentation, stronger internal alignment, and more confident submission planning.
250+ ProjectsSuccessful regulatory and compliance engagements completed.200+ Product TypesExperience across diverse medical device categories.90% Audit ClearanceStrong track record in audit and inspection readiness.
Frequently Asked Questions
What is a Software as a Medical Device Training Course?
A Software as a Medical Device Training Course teaches teams how software products are regulated when they meet the definition of a medical device. It typically covers SaMD classification, intended use, software lifecycle controls, risk management, clinical and performance evidence, quality system expectations, and documentation needed for submissions in markets such as the US, EU, Canada, and Australia.
Who should attend SaMD regulatory training?
SaMD training is valuable for regulatory affairs professionals, software developers, quality teams, product managers, clinical teams, founders, and project leads involved in digital health products. It is especially useful when teams need shared understanding across IEC 62304, ISO 14971, quality system requirements, and market-specific submission expectations so decisions made during development support compliance later.
What topics are usually covered in a SaMD training course?
Most strong SaMD courses cover device classification, intended use and claims, regulatory pathway selection, software lifecycle documentation, cybersecurity considerations, risk management, usability, clinical evidence strategy, quality system alignment, and submission readiness. Advanced training may also address FDA pre-submissions, EU MDR software rules, TGA expectations, Health Canada requirements, and post-market obligations for software changes and complaint handling.
Does the course cover IEC 62304 and ISO 14971?
Yes, these are core topics for most serious SaMD training programs. IEC 62304 helps teams understand software lifecycle processes, including development, maintenance, and problem resolution, while ISO 14971 focuses on identifying hazards, evaluating risks, and documenting controls. Together, they form a practical foundation for building compliant software documentation and supporting regulatory submissions.
Can this training help us prepare for FDA or EU submissions?
Yes. Effective SaMD training helps teams understand what regulators expect before a submission is assembled. It can improve classification decisions, documentation structure, traceability, risk files, software evidence, and claims alignment. While training alone does not replace submission consulting, it reduces avoidable mistakes and helps internal teams contribute more effectively to FDA, EU MDR, TGA, or Health Canada preparation.
Is this course suitable for startups developing digital health products?
Yes, startups often benefit significantly because early product decisions can create major downstream regulatory consequences. A SaMD course helps founders and product teams understand whether their software is regulated, what documentation should begin early, how quality systems affect development, and which standards matter most. That knowledge can reduce rework, improve planning, and support investor and market-entry readiness.
How long does SaMD training usually take?
Course length depends on depth and audience. Introductory sessions may run a few hours, while more comprehensive training can span one to several days with workshops, case studies, and documentation reviews. For organizations building internal capability, multi-session formats often work best because they allow teams to absorb concepts, ask role-specific questions, and apply lessons to active products.
What outcomes should we expect after completing the course?
Teams should leave with clearer understanding of SaMD classification, applicable standards, documentation priorities, and regulatory pathways. A good course also improves cross-functional alignment between software, quality, clinical, and regulatory teams. In practical terms, that often means better traceability, stronger risk documentation, more realistic submission planning, and fewer compliance gaps discovered late in development or review.
Still Have Questions About SaMD Training?
Speak with our experts about course scope, audience, and delivery options.
Certified & Trusted
Awards and Recognition
ISO 13485
Medical device quality system expertise.
IEC 62304
Software lifecycle compliance knowledge.
MDSAP
Multi-market audit readiness support.
