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.
We are pleased to welcome Helene Wu, Ph.D. to the GessNet team. GessNet combines expert consulting with purpose-built digital solutions to help life-science companies connect and streamline product development, quality, risk management, and regulatory execution around product safety and effectiveness.
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GessNet is partnering with Eco-Inject to engineer a fully traceable autoinjector platform, connecting requirements, risk, and evidence from early development through commercial launch.
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GessNet has launched the Safe and Effective AI for Medical Products (SEAI) initiative, a structured effort to define how AI can be applied responsibly within regulated medical-product development.
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We are pleased to welcome Helene Wu, Ph.D. to the GessNet team. GessNet combines expert consulting with purpose-built digital solutions to help life-science companies connect and streamline product development, quality, risk management, and regulatory execution around product safety and effectiveness.
Read moreA 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.
Read insightGessNet is partnering with Eco-Inject to engineer a fully traceable autoinjector platform, connecting requirements, risk, and evidence from early development through commercial launch.
Read moreGessNet has launched the Safe and Effective AI for Medical Products (SEAI) initiative, a structured effort to define how AI can be applied responsibly within regulated medical-product development.
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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 has welcomed Jian Cao, Ph.D., to the team, strengthening the organization's program and portfolio leadership.
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GessNet presented a tutorial at IMSC26 on turning risk files into a clear, credible safety story -- moving beyond a compliant-looking file to one that actually demonstrates a device is safe and effective.
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GessNet has welcomed Frank Li, MD, PhD, to the team, strengthening the organization's regulatory and clinical expertise.
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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 GessNet contribution on best practices for applying risk management terminology consistently, published in Biomedical Instrumentation & Technology.
View publicationA GessNet contribution on risk management and safety cases for medical devices, published in Biomedical Instrumentation & Technology.
View publicationA GessNet contribution on documenting medical device risk management using a risk traceability summary, published in Biomedical Instrumentation & Technology.
View publicationA GessNet contribution on reducing risk and recalls through safety assurance cases for medical devices, 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.