GessNet
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Customer Stories

How organizations use QMSpace and GessNet

Customer and collaborative applications range from first-principles regulatory science and enterprise combination-product digitalization to integrated eQMS, reusable delivery-device platforms, and novel medical technologies. Each story focuses on the development context and connected operating model rather than unsupported performance claims.

Collaborative regulatory-science initiative

MD PnP / Center for SaAMS

Building a first-principles safety framework for smart and autonomous medical systems

The application

MD PnP is using QMSpace to develop a first-principles-based safety framework for Smart and Autonomous Medical Systems (SaAMS), creating a connected structure for system intent, risks, safety requirements, controls, test methods, objective evidence, and safety arguments. The work supports a shared technical framework in which innovators and regulators can collaborate as both the technology and regulatory science evolve.

Relevant GessNet capabilities

QMSpaceSaAMSFirst-Principles SafetyRegulatory ScienceSafety Assurance

How QMSpace supports the work

  • Connect clinical and system intent to architecture, hazards, risks, safety requirements, controls, tests, and evidence.
  • Structure first-principles safety reasoning as a living, traceable framework.
  • Support shared risk models, safety arguments, and precompetitive regulatory-science work.
  • Enable evidence-based collaboration among innovators, researchers, clinicians, and regulators.

Established pharmaceutical company

Merck

Digitalizing combination-product design controls and risk management

The application

Merck is using QMSpace to connect combination-product design controls and risk management, organize objective evidence, and build reusable digital libraries and platform structures that support consistency across programs.

Relevant GessNet capabilities

QMSpaceDigital Knowledge ServicesCombination Products

How QMSpace supports the work

  • Connect design-control and risk-management records in one governed context.
  • Create reusable libraries for requirements, risks, controls, and evidence structures.
  • Distinguish shared platform knowledge from product-specific information.
  • Maintain traceability and improve visibility when shared knowledge changes.

Drug-delivery platform startup

Eco-Inject

Connecting eQMS with a reusable platform for multiple combination products

The application

Eco-Inject uses QMSpace as an integrated eQMS and product-development environment while developing an innovative drug-delivery device platform intended to support multiple combination products. Quality processes, design controls, risk management, requirements, evidence, and reusable platform knowledge can therefore mature together rather than in disconnected systems.

Relevant GessNet capabilities

QMSpaceeQMSPlatform DevelopmentDesign ControlsRisk Management

How QMSpace supports the work

  • Establish and operate the electronic quality-management foundation.
  • Define reusable device-platform knowledge and applicability rules.
  • Manage shared and program-specific requirements, CQAs, risks, controls, and evidence.
  • Connect quality-system processes with product-specific design-control and risk-management execution.

Novel medical-technology startup

Cordance Medical

Connecting eQMS with innovative medical-device development

The application

Cordance Medical uses QMSpace as an integrated eQMS and product-development environment to manage quality processes while establishing connected requirements, risk management, design controls, traceability, and objective evidence for an innovative medical-device development program.

Relevant GessNet capabilities

QMSpaceeQMSNovel TechnologyRisk ManagementTraceability

How QMSpace supports the work

  • Establish and operate the electronic quality-management foundation.
  • Connect intended use, requirements, risks, controls, and evidence.
  • Maintain end-to-end development traceability.
  • Coordinate quality-system maturity with design-control, risk-management, and regulatory-readiness execution.

Enterprise medical-device organization

Established medical-device company

Connecting documents, spreadsheets, and legacy systems

The application

A well-established medical-device organization is implementing QMSpace as a first-principles digital backbone across documents, spreadsheets, and legacy systems. The objective is to connect critical lifecycle knowledge without requiring disruptive replacement of every existing system.

Relevant GessNet capabilities

QMSpaceEnterprise DigitalizationSystems IntegrationLifecycle Management

The organization is described anonymously at its request.

How QMSpace supports the work

  • Create a connected product context across fragmented information sources.
  • Clarify relationships among requirements, risks, evidence, and quality processes.
  • Improve lifecycle and change-impact visibility.
  • Build a foundation for controlled reuse and future digital intelligence.

Established cGMP pharmaceutical organization entering combination products

Established pharmaceutical company

Extending a mature pharmaceutical QMS for combination products, with minimal disruption

The application

An established pharmaceutical company with a mature, cGMP-compliant quality system is entering the drug-device combination-product space for the first time. Rather than creating a separate device quality system or significantly changing established pharmaceutical processes, the company is taking a streamlined approach: preserving the quality-system infrastructure that already works while using QMSpace eQMS capabilities to fill missing device- and combination-product quality-system gaps. QMSpace is also used for product-specific design controls, ISO 14971-based risk management, traceability, documentation, and regulatory submission evidence.

Relevant GessNet capabilities

QMSpace eQMSCombination ProductsQMS & Audit ReadinessQMSR / ISO 13485Design ControlsISO 14971 Risk ManagementTraceabilityRegulatory Submissions

The organization is described anonymously at its request.

How QMSpace supports the work

  • Preserve mature cGMP processes and established ways of working where they remain appropriate, minimizing unnecessary impact to the existing pharmaceutical QMS.
  • Use QMSpace eQMS capabilities to fill the missing device- and combination-product quality-system processes, workflows, records, responsibilities, and controls needed to support QMSR and ISO 13485 expectations.
  • Manage intended use, user needs, CQAs, requirements, design outputs, hazards, risks, risk controls, verification, validation, and supporting evidence within a connected product-development environment.
  • Connect the additional eQMS processes directly to the product-specific records and evidence they govern.
  • Maintain end-to-end traceability across requirements, risks, controls, design outputs, verification, validation, quality records, and lifecycle decisions.
  • Streamline product documentation and regulatory submission preparation through connected design, risk, quality, verification, and validation evidence.

See how QMSpace could support your development environment

A tailored demonstration can focus on the customer application most similar to your product, organization, systems, and lifecycle priorities.

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