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Practical thinking for complex medical-product development
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.
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News ReleaseNew Team Member2026-10-15
Welcome Helene Wu, Ph.D. to the GessNet team
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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News ReleaseTraceability2026-04-24
Eco-Inject and GessNet Partner to Engineer a Fully Traceable Autoinjector Platform
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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News ReleaseDigital Knowledge2026-04-22
Launching the Safe and Effective AI for Medical Products (SEAI) Initiative
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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19 insights shown
News ReleaseNew Team Member2026-10-15
Welcome Helene Wu, Ph.D. to the GessNet team
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 morePractical GuideCombination Products2026-08-05
Closing Quality-System Gaps Before Combination-Product Execution
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 insightArticleTraceability2026-08-05
Connecting Requirements, Risk, and Evidence in One Traceable Structure
Why traceability becomes more useful when it represents the logic of product development rather than merely linking documents for an audit.
Read insightArticleEnterprise Scale2026-08-05
Structured Reuse as an Enterprise Capability
How governed digital knowledge can preserve proven requirements, risks, controls, and evidence while keeping product-specific distinctions visible.
Read insightNews ReleaseTraceability2026-04-24
Eco-Inject and GessNet Partner to Engineer a Fully Traceable Autoinjector Platform
GessNet is partnering with Eco-Inject to engineer a fully traceable autoinjector platform, connecting requirements, risk, and evidence from early development through commercial launch.
Read moreNews ReleaseDigital Knowledge2026-04-22
Launching the Safe and Effective AI for Medical Products (SEAI) Initiative
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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ArticleDigital Knowledge2026-04-17
AI in Regulated Environments: A Question of Governance, Not Just Accuracy
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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News ReleaseEnterprise Scale2026-04-15
Welcoming Jian Cao, Ph.D. to Strengthen Program and Portfolio Leadership
GessNet has welcomed Jian Cao, Ph.D., to the team, strengthening the organization's program and portfolio leadership.
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News ReleaseRisk Management2026-04-10
IMSC26 Tutorial: Turning Risk Files into a Clear, Credible Safety Story
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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News ReleaseRegulatory Evidence2026-04-10
Welcoming Frank Li, MD, PhD, to Strengthen Regulatory and Clinical Expertise
GessNet has welcomed Frank Li, MD, PhD, to the team, strengthening the organization's regulatory and clinical expertise.
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ArticleRisk Management2026-04-03
What Does 'Good' Risk Management Really Look Like?
GessNet's perspective on what 'good' risk management really looks like in practice — read the full post on LinkedIn.
Read insightExternal PublicationCombination Products2026-03-06
Engineering Safety and Effectiveness: A First-Principles Approach to Drug-Device Combination Products
In 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 publicationExternal PublicationRisk Management2019-09-01
Reducing Time To Market and Promoting Innovation while Ensuring Device Safety
A GessNet contribution on balancing faster time-to-market with device safety and innovation, published in Biomedical Instrumentation & Technology.
View publicationExternal PublicationRisk Management2019-01-01
Advancing Regulatory Science through Comprehensive, Rational Risk Management
A GessNet contribution on applying comprehensive, rational risk management to advance regulatory science, published in Biomedical Instrumentation & Technology.
View publicationExternal PublicationRisk Management2016-01-01
Cybersecurity Risk Management for Device Manufacturers
A GessNet contribution on cybersecurity risk management practices for medical device manufacturers, published in Biomedical Instrumentation & Technology.
View publicationExternal PublicationRisk Management2015-01-01
Best Practices in Applying Risk Management Terminology
A GessNet contribution on best practices for applying risk management terminology consistently, published in Biomedical Instrumentation & Technology.
View publicationExternal PublicationRisk Management2015-01-01
Medical Device Risk Management and Safety Cases
A GessNet contribution on risk management and safety cases for medical devices, published in Biomedical Instrumentation & Technology.
View publicationExternal PublicationTraceability2015-01-01
Documenting Medical Device Risk Management through the Risk Traceability Summary
A GessNet contribution on documenting medical device risk management using a risk traceability summary, published in Biomedical Instrumentation & Technology.
View publicationExternal PublicationRisk Management2014-01-01
Reducing Risks and Recalls: Safety Assurance Cases for Medical Devices
A GessNet contribution on reducing risk and recalls through safety assurance cases for medical devices, published in Biomedical Instrumentation & Technology.
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