Classification of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)
Navigate the complexities of software classification under the Medical Device Regulation, so that you can ensure compliance and avoid regulatory pitfalls. Attend this course to gain expert insights, so that you can confidently apply the MDCG guidelines and enhance your approach to medical device software classification.
Join us for an insightful course delving into the complexities of software classification under the Medical Device Regulations. With the flawed Classification Rule 11 you need expert advice to navigate this opaque topic effectively. This course, led by a key participant in the drafting process of the Medical Device Coordinators Group (MDCG) guidance, provides invaluable context to help you read between the lines and understand the true intent behind its wording. Don’t let the convoluted language and cautious interpretations by regulators trip you up.
The course includes comprehensive case studies to solidify your understanding, allowing you to apply what you've learned to real-world scenarios. With our expert course leader's insider perspective, you will get a clear interpretation of the MDCG guidelines, ensuring you are well-prepared to navigate and apply them in your work.
We will also explore the Helsinki Procedure, a crucial framework for resolving disputes and providing guidance on challenging classification issues.
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Benefits of attending
By attending this course, you will:
- Examine the implementation and classification rules
- Understand what is behind the convuluted MDCG language
- Master the key concepts to classify medical device software
- Learn how to apply the classification rules to real-world examples
- Explore your options when faced with a disagreeing notified body or unfair competition
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About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...