Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) In-house Training

Course overview

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.

This course is part of our range of Medical Devices training courses

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 authorisation 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 authorisation 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

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