3-Day Offline SaMD Training by AptSkill: Master Software as a Medical Device Regulation

Join AptSkill's intensive 3-day offline SaMD training in India. Hands-on sessions on classification, lifecycle documentation, AI/ML in regulatory submissions, and real-world case studies for MedTech teams.

Building In-House SaMD Expertise, One Intensive Workshop at a Time

Software as a Medical Device (SaMD) is one of the fastest-growing — and most misunderstood — categories in the MedTech world. Unlike traditional hardware devices, SaMD products live and evolve continuously: new software versions, AI/ML model updates, and cybersecurity patches all carry regulatory weight. Teams that don't build strong internal SaMD competency early often struggle later with classification disputes, incomplete technical documentation, or delayed Notified Body reviews.

That's why AptSkill has designed a focused, 3-day offline SaMD training program — a deep, hands-on workshop built specifically for MedTech companies developing standalone software, mobile health apps, AI-based diagnostic tools, or connected digital health platforms.

This isn't a passive lecture series. It's a working session where your team leaves with real documentation templates, classification decisions made on your own products, and a clear regulatory roadmap.

Why a Dedicated 3-Day Format?

SaMD regulation touches multiple disciplines at once — software engineering, clinical evidence, cybersecurity, quality management, and regulatory strategy. A single half-day session can't do justice to that complexity. Our 3-day structure allows:

• Day 1 to build strong conceptual and classification foundations

• Day 2 to go deep into lifecycle documentation and technical files

• Day 3 to apply everything through case studies, mock audits, and Q&A specific to your product

This progressive structure ensures teams don't just hear about SaMD — they leave having actually built the documentation skeleton for their own product.

3-Day Training Agenda

Day 1: Foundations & Classification

• What qualifies as SaMD vs. SiMD (Software in a Medical Device)

• Global regulatory landscape: EU MDR/IVDR, FDA, IMDRF risk categorization framework

• Classification workshop using your own product examples

• Intended use statements and their regulatory implications

• Overview of applicable standards: IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1

Day 2: Lifecycle Documentation & Technical Files

• Software Development Lifecycle (SDLC) documentation requirements

• Risk management specific to software (hazard analysis, software-related risk controls)

• Verification & Validation (V&V) planning and traceability matrices

• Cybersecurity documentation expectations (pre-market and post-market)

• Building a SaMD Technical Documentation package: hands-on exercise

• Change management and version control documentation

Day 3: AI/ML, Case Studies & Audit Readiness

• Regulatory considerations for AI/ML-based SaMD (algorithm change protocols, predetermined change control plans)

• Clinical evaluation and performance evidence for SaMD

• Post-market surveillance and complaint handling for software products

• Mock regulatory audit: role-play and documentation review

• Open case study session using participant company products

• Q&A, gap analysis, and personalized roadmap discussion

Who Should Attend

• Regulatory Affairs and Quality Assurance teams working on software-based devices

• Software engineering and product teams building connected or AI-enabled health products

• Clinical and medical affairs teams supporting SaMD evidence generation

• Startups preparing their first SaMD regulatory submission

• Established manufacturers expanding into digital health or AI diagnostics

Fully Customizable to Your Product Portfolio

While the 3-day structure above is our recommended flow, every session is tailored before delivery:

• Product-specific classification workshops using your actual intended use and risk profile

• Target market focus (EU MDR/IVDR, US FDA, India CDSCO, or multi-market strategy)

• Depth adjustment based on whether your team is early-stage or already has a QMS in place

• Flexible group size and venue — delivered at your facility or a location of your choice, anywhere in India

• Optional add-on modules, such as IEC 62304 deep-dive, human factors/usability engineering, or predetermined change control plans for AI/ML products

Before the training, AptSkill conducts a pre-session scoping call with your team to align the agenda, exercises, and case studies with your real regulatory priorities.

What Your Team Walks Away With

• A working SaMD classification decision for your own product(s)

• Draft technical documentation templates ready to adapt internally

• A clear understanding of AI/ML-specific regulatory expectations

• Practical experience through mock audits and case studies

• A personalized gap analysis and regulatory roadmap for next steps

Why AptSkill

AptSkill brings deep, hands-on regulatory affairs expertise across the full MedTech spectrum — including SaMD, EU MDR, ISO 13485, ISO 14971, and FDA 21 CFR 820 — combined with a strong track record of building practical, in-person training programs for MedTech companies across India. Our trainers don't just teach the regulation; they help your team apply it to your own products, in the room, in real time.

Book Your 3-Day SaMD Training

Ready to build real in-house SaMD capability for your team? Get in touch with AptSkill to schedule your customized 3-day offline training.

📧 Email: aptskill6@gmail.com 📞 Phone: +91 8262083746