Presented by
Management Forum
Gain essential knowledge in developing and managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW), focusing on regulatory compliance, risk management, and lifecycle management to ensure safety and effectiveness.
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Master best practices in regulated software development so that you can balance flexibility and control, enabling innovation early on while ensuring rigorous oversight and regulatory compliance as projects progress.
Best practices for the development and management of regulated software are straightforward, but the challenge lies in effectively implementing them without stifling creativity. This skill is essential for delivering a final build that is reliable, safe, and compliant with regulatory requirements. Early on, allow your team to explore and experiment—later, tighten the reins, meticulously assess code impacts, and conduct targeted testing to maintain system integrity without incurring exorbitant costs or risking regulatory implications. This nuanced balance is best learned through practical experience and informed guidance, which this course offers in abundance.
From studying different software development models and managing design activities to understanding state-of-the-art standards and effective outsourcing strategies, you will gain insights to avoid the pitfalls of poor software development. Practical case studies will illuminate real-world challenges and solutions, guiding you through the complexities of regulatory compliance and optimal project management. Led by an expert with extensive hands-on experience, this course provides the strategies and knowledge to transform your development process, ensuring your products meet the highest standards of quality and safety.
This course covers crucial topics such as:
Through hands-on case studies and expert-led discussions, you’ll learn to navigate the complex regulatory landscape and apply proven strategies to ensure your software’s success. Whether tackling system usability or evaluating risks throughout the product lifecycle, this course provides the tools and knowledge you need.
Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.
By attending this course you will:
Professionals involved in software development and regulatory compliance withing the medical device industry, including:
United Kingdom
1 day
Typical duration
Pricing from:
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: