AptSkill

SaMD: From Classification to FDA and EU Strategy

SaMD Masterclass โ€“ AptSkill MedTech
Live Masterclass ยท May 2, 2026

SaMD: From Classification
to FDA & EU Strategy

Live Masterclass for MedTech Professionals

Live & Interactive
120 Minutes
Includes Q&A
Expert-Led
Reserve Your Seat

Only USD 199 ยท Secure online payment

๐Ÿ“…
Date
Saturday, May 2nd, 2026
๐Ÿ•™
Time
10:00 AM โ€“ 12:00 PM ET
โฑ๏ธ
Duration
120 Minutes
๐Ÿ’ป
Format
Live Online

Why This Training Matters

Software as a Medical Device (SaMD) is one of the fastest-evolving and most complex areas in medical device regulation. As healthcare increasingly relies on software-driven diagnostics, clinical decision support, and AI-powered tools, companies must navigate a demanding dual regulatory landscape โ€” the FDA in the United States and the MDR framework in the European Union.

Getting your regulatory strategy wrong can mean costly delays, rejection, or market exclusion. This 2-hour live masterclass delivers practical, actionable clarity for professionals working in regulatory affairs, quality assurance, product development, and MedTech engineering.

๐ŸŽฏ Who should attend: Regulatory Affairs specialists, Quality Managers, Software engineers in MedTech, Product managers, and anyone in the medical device space working with or evaluating software-based solutions.

What You Will Learn

1
How to determine whether your software qualifies as SaMD under international definitions and frameworks
2
FDA regulatory pathways โ€” 510(k), De Novo, and PMA โ€” and when each applies to SaMD products
3
EU MDR regulatory approach, classification rules, and key documentation requirements for software
4
AI & ML considerations โ€” adaptive algorithms, predetermined change control plans, and emerging FDA guidance
5
Cybersecurity considerations โ€” FDA’s latest premarket and postmarket cybersecurity guidance for SaMD
6
Common regulatory pitfalls and how to avoid delays, submission rejections, or costly rework

Led by a Certified MedTech Expert

๐Ÿ‘ฉโ€โš•๏ธ
RAC Certified

MedTech Regulatory Professional

Led by a RAC-certified MedTech professional with deep industry experience spanning FDA submissions, EU MDR compliance, SaMD classification strategy, and regulatory consulting. The session brings real-world case studies and practical frameworks you can apply immediately after the masterclass.

Enrollment Fee

One-time enrollment ยท Full 2-hour live session

$199
USD per participant
โš ๏ธ Limited seats available to ensure an interactive experience

Enrollment includes live session access, interactive Q&A with the instructor, and access to materials shared during the masterclass.

Secure Your Spot Today

Enter your details below, then complete payment via PayPal to confirm your seat.

Reserve Your Seat

May 2nd, 2026 ยท 10 AMโ€“12 PM ET ยท USD 199

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๐Ÿ”’ 256-bit SSL encrypted ยท Secure checkout by PayPal

AptSkill MedTech ยท AptSkillMedTech.com

Questions? Reach out via our website. ยฉ 2026 AptSkill MedTech. All rights reserved.