The "Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course (Nov 10th - Nov 11th, 2025)" training has been added to ResearchAndMarkets.com's offering.

Join this two-day training course to master the intricate decisions on product claims, technologies, and regulatory positioning that software manufacturers face.

These choices significantly impact the market authorisation process and can determine your success. Avoid missteps that lead to delays, increased costs, and denied market entry. Ensure your innovation reaches its full potential worldwide.

Emerging technologies like digital therapeutics, machine learning, and cloud computing add layers of complexity. Distinguishing between medical and non-medical software, understanding international differences, and meeting diverse market authorisation requirements are some of the significant challenges you'll encounter.

In this course, you will gain a clear understanding of global medical device software regulations. We'll provide practical insights, hands-on exercises, and case studies to guide you through the intricate decisions needed that affect your market authorisation processes. You'll leave equipped to confidently bring your software to market and ensure its regulatory success.

Benefits of attending

By attending this course, you will:

• Examine the borderline between general health and wellness, medical and pharmaceutical software.
• Master the criteria that qualify software as a medical device
• Learn how claim and technology decisions are linked to market authorization obligations
• Get to grips with the regulatory concepts of configurable devices, accessories, systems, and parts, and how leveraging them for your regulatory positioning can impact your administrative burden
• Identify the pros and cons of splitting your software into platforms and modules
• Expand your understanding of the EU and US market authorization process and its obligations for software products
• Get up to date with how different distribution models such as direct download, app stores, cloud-based, and subscription models bring different economic operator obligations
• Understand a health institution's obligations, opportunities and limitations for in-house development
• Place yourself in the shoes of a start-up and weigh your regulatory options, strategy, timing, and budget decisions

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

Who Should Attend:

• Business strategists
• Product and service managers
• Sales and marketing managers
• Regulatory affairs managers
• Legal professionals
• Compliance officers
• Research and development engineers
• Clinical research associates
• Project managers
• Clinical informatics managers of hospitals

Key Topics Covered:

Day 1

Introduction to the regulations

• Exploratory exercise to discover the borderline between medical device, pharmaceutical, and cosmetic regulation through a case study

Is it a medical device or not?

• Medical device and in vitro diagnostic device definitions, their terminology, and software considerations
• Intended purpose and claim specificity
• Borderline between medical device software and lifestyle and fitness software

Software qualification

• Modules and software with multiple functions
• Functional exemptions
• Population health and educational software
• Search engines, Q&A tools, and chatbots
• Resource and workflow management software
• Clinical decision software

International comparison

• Software as a Medical Device (SaMD) according to the IMDRF
• SaMD ≠ Medical Device Software
• IMDRF SaMD risk stratification framework and its pitfalls
• International differences (US, Canada, South Korea, .)

Case studies on qualification

Considerations for placement on the market

• Placing and making available on the market
• Subscription models, cloud computing, and software as a service
• Pros and cons of the modular approach
• Software platforms
• Software accessories, systems, components
• Legal status of wearables

Case study on regulatory positioning

Case study on wearables

Borderline with medicine legislation

• Companion diagnostics, medication management, and adherence apps
• Digital therapeutics
• Borderline with pharmaceuticals, combination products

Case study on borderline with medicine legislation

Day 2

EU market authorisation of medical device software

• Overview of EU market authorization process
• Engaging with a Notified Body
• UDI versus Basic UDI
• EUDAMED
• Declaration of Conformity
• Person Responsible for Regulatory Compliance
• Authorized representatives
• Economic operators: distributors, importers, and service fulfillment centers
• App Stores and Digital Distribution Platforms
• Software traceability
• Monitoring critical components or platform updates
• Software recalls
• Unannounced Notified Body Audits
• Service updates, upgrades, and other changes

Case study on software distribution

Case study: a great idea for a start-up!

General safety and performance requirements for software

• Harmonised standard
• Common specifications
• GSPR Checklist
• Software labelling
• Use of language and symbols
• IT environment and mobile platforms
• Repeatability and reliability of machine learning software
• Instructions for use

Practical construction of a technical file

• Content
• Example

US market authorisation (FDA)

• US Code of Federal Regulations and its Implications for Software
• 510(k) process and de novo process
• FDA Guidances specific to software
• FDA expectations for machine learning software

Case study on US market authorisation

Discussion - international go-to-market considerations

For more information about this training visit https://www.researchandmarkets.com/r/67i8lf

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