SaMD: From Classification to FDA and EU Strategy

SaMD Masterclass โ€“ AptSkill MedTech
Live Masterclass ยท May 16, 2026

SaMD: Quality & Regulatory
Perspectives

Live Masterclass for MedTech Professionals

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

Only โ‚น999 ยท Secure online payment

๐Ÿ“…
Date
Saturday, May 16th, 2026
๐Ÿ•™
Time
4:00 PM โ€“ 5:30 PM IST
โฑ๏ธ
Duration
90 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 90-minute live masterclass delivers practical, actionable clarity on both quality and regulatory perspectives 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
Introduction to SaMD โ€” definitions, scope, and the international regulatory framework
2
US Regulations on SaMD โ€” FDA pathways, classification, and submission requirements
3
EU Regulations on SaMD โ€” MDR classification rules and key documentation requirements for software
4
Cybersecurity Consideration โ€” FDA’s latest premarket and postmarket cybersecurity guidance for SaMD
5
AI & ML Considerations โ€” adaptive algorithms, predetermined change control plans, and emerging FDA guidance
6
Questions and Answers โ€” live interactive session with the instructor to address your specific challenges

Your Instructor

๐Ÿ‘ฉโ€โš•๏ธ

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 90-minute live session

โ‚น999
INR 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 to confirm your seat.

Reserve Your Seat

May 16th, 2026 ยท 4 PMโ€“5:30 PM IST ยท โ‚น999

๐Ÿ” Pay Securely ยท โ‚น999
๐Ÿ”’ 256-bit SSL encrypted ยท Secure checkout

AptSkill MedTech ยท AptSkillMedTech.com

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