Explore GessNet articles and practical guidance on combination products, design controls, risk management, systems engineering, digital knowledge, traceability, regulatory evidence, and accountable AI-assisted development.
13 insights shown
A practical sequence for identifying the device and combination-product capabilities that a pharmaceutical quality system must add without duplicating systems that already work.
Read insightWhy traceability becomes more useful when it represents the logic of product development rather than merely linking documents for an audit.
Read insightHow governed digital knowledge can preserve proven requirements, risks, controls, and evidence while keeping product-specific distinctions visible.
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GessNet's take on why deploying AI in regulated environments requires governance frameworks, not just model accuracy — read the full post on LinkedIn.
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GessNet's perspective on what 'good' risk management really looks like in practice — read the full post on LinkedIn.
Read insightIn this article, we examine common root causes behind regulatory setbacks, development delays, and failures to adequately address patient needs. We discuss the first principles of safety and how applying these principles helps organizations stay focused and navigate...
View publicationA GessNet contribution on balancing faster time-to-market with device safety and innovation, published in Biomedical Instrumentation & Technology.
View publicationA GessNet contribution on applying comprehensive, rational risk management to advance regulatory science, published in Biomedical Instrumentation & Technology.
View publicationA GessNet contribution on cybersecurity risk management practices for medical device manufacturers, published in Biomedical Instrumentation & Technology.
View publicationA tailored discussion can connect the principles in these articles to your quality-system, product-development, or digital-transformation priorities.
