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
Course Content
Day 1
