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Articles


Keeping Microfluidic Product Development Costs Down
Cost-effective development of microfluidic and IVD products is not achieved by simply reducing spend—it is achieved through informed decision-making, early risk reduction, and strategic planning across the entire development lifecycle. At Device Scope, we support teams in optimising development efficiency while maintaining technical robustness, regulatory compliance, and commercial viability. Start with Clear Requirements & Investor Alignment A strong foundation begins with a
4 min read


How Strategy & Technical Workshops Accelerate IVD Product Development
In the development of microfluidic and IVD products, progress is often constrained not by effort, but by unresolved technical issues, misalignments, or unanticipated challenges. Strategy and technical workshops provide a structured and highly effective way to address these challenges—bringing the right expertise together at the right time to accelerate decision-making, reduce risk, and keep development programmes on track. Why Workshops Add Value Customised strategy, planning
3 min read


Building Robust IVDs – Fundamentals of regulated product development (Part 1)
The Hierarchy of regulatory requirements In established medical device and IVD markets, regulatory requirements are structured in a clear hierarchy. Laws define the legal obligations manufacturers must meet. These are supported by regulations, which translate the law into more detailed, enforceable requirements. Finally, guidelines and technical standards sit beneath regulations, providing practical guidance on how compliance can be achieved. Why regulation matters in IVD d
3 min read
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