Developing and Managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW) In-house Training

Course overview

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:

• managing software suppliers
• designing and evaluating the product’s user experience
• managing safety risks
• state-of-the-art standards like IEC 62304 and IEC 82304-1
• techniques for effective risk control and communication

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.

Benefits of attending

By attending this course you will:

• Learn best practices for compliant software development and management while keeping the administrative burden at bay
• Examine essential techniques to improve product quality and ensure business continuity given employee turnover and continuously changing IT environments
• Consider the advantages of automating documentation practices
• Identify real-world stories to help you motivate your team to follow best practices rather than threatening them with looming regulatory findings
• Get up to date with how state-of-the-art standards are evolving
• Master user experience evaluation techniques
• Get to grips with risk management terminology, techniques and strategies
• Understand how to communicate in times of crises

Who should attend?

Professionals involved in software development and regulatory compliance withing the medical device industry, including:

• Software developers
• Project managers
• Product managers
• System analysts
• Biomedical engineers
• Risk management moderators
• Clinical validation specialists
• Usability engineers
• Technical writers
• Regulatory affairs specialists
• Quality assurance engineers
• Clinical informatics managers of hospitals