Quality Management Software for Medical Device Manufacturers
NeuSoft is a practical, scalable and accessible SaaS-based, quality management software for medical devices, giving manufacturers one connected system for documents, risk files, design control, deviations and CAPA, training, audits, assets and supplier management. It replaces scattered spreadsheets, shared folders, paper records and email approvals with structured, traceable digital workflows.
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What is NeuSoft
NeuSoft as an eQMS software and is a brand of Neujin Solutions – one of India's top regulatory consultants for medical devices. Developed with over twenty years of domain expertise, NeuSoft is a software that aims to be the default software for SME medical device manufacturers globally.
Eight Connected Modules. Scalable one at a time.
The eight connected modules complete the entire Quality Management System. While the Document Management Module is core to the eQMS, you have the option to scale up by adding the other modules one by one.
Document Management System
Control the complete lifecycle of policies, SOPs, work instructions, forms, specifications and quality records.
Read MoreRisk Management System
Maintain structured risk files with traceability between hazards, risks, controls and verification evidence.
Read MoreDesign Control & DHF Management
Connect design planning, inputs, outputs, reviews, verification, validation, transfer and changes.
Read MoreDeviation Management
Manage deviations and related non-conformities through structured workflows, from investigation through corrective action and closure.
Read MoreTraining & Competency Management
Assign role-based training, monitor completion and maintain competency evidence.
Read MoreInternal Audit Management
Plan audits, complete structured checklists, document findings and track follow-up activities.
Read MoreAsset Management
Control equipment inventories, calibration, maintenance, qualification status and supporting records.
Read MoreSupplier Management
Apply risk-based controls to supplier selection, agreements, scheduled activities and performance monitoring.
Read MoreDocument Management System
Control the complete lifecycle of policies, SOPs, work instructions, forms, specifications and quality records.
Read MoreRisk Management System
Maintain structured risk files with traceability between hazards, risks, controls and verification evidence.
Read MoreDesign Control & DHF Management
Connect design planning, inputs, outputs, reviews, verification, validation, transfer and changes.
Read MoreDeviation Management
Manage deviations and related non-conformities through structured workflows, from investigation through corrective action and closure.
Read MoreTraining & Competency Management
Assign role-based training, monitor completion and maintain competency evidence.
Read MoreInternal Audit Management
Plan audits, complete structured checklists, document findings and track follow-up activities.
Read MoreAsset Management
Control equipment inventories, calibration, maintenance, qualification status and supporting records.
Read MoreSupplier Management
Apply risk-based controls to supplier selection, agreements, scheduled activities and performance monitoring.
Read MoreDocument Management System
Control the complete lifecycle of policies, SOPs, work instructions, forms, specifications and quality records.
Read MoreRisk Management System
Maintain structured risk files with traceability between hazards, risks, controls and verification evidence.
Read MoreDesign Control & DHF Management
Connect design planning, inputs, outputs, reviews, verification, validation, transfer and changes.
Read MoreDeviation Management
Manage deviations and related non-conformities through structured workflows, from investigation through corrective action and closure.
Read MoreTraining & Competency Management
Assign role-based training, monitor completion and maintain competency evidence.
Read MoreInternal Audit Management
Plan audits, complete structured checklists, document findings and track follow-up activities.
Read MoreAsset Management
Control equipment inventories, calibration, maintenance, qualification status and supporting records.
Read MoreSupplier Management
Apply risk-based controls to supplier selection, agreements, scheduled activities and performance monitoring.
Read MoreSimple, Scalable, Accessible
Scalable, one module at a time
Add modules when you need them. Each one connects to the records already in the system, with no second implementation.
Start with the module you need most, then add others as you grow. Each one connects to what's already there — no re-entry, no second implementation project.
Simple by design
Clear screens and short paths to every record. Your team learns it in hours, and nothing decorative slows the system down.
Clear screens, short paths to every record. Your team learns it in hours, not weeks — nothing on screen exists unless an auditor or approver actually needs it.
Connected workflows
A record created in one module becomes the input to the next. Hazard to control to verification, finding to CAPA to effectiveness check.
A record created in one module feeds the next — hazard to control to verification, finding to CAPA to effectiveness check. Nothing re-keyed, nothing orphaned.
Built for SMEs
Priced for small and mid-sized manufacturers, without enterprise licensing or paid configuration work.
Priced for small and mid-sized manufacturers — no enterprise licensing, no paid configuration work, no consultant required. You pay only for the modules you use.
Common questions
NeuSoft can manage policies, SOPs, work instructions, forms, specifications and supporting quality records.
Yes. Native Word and Excel import is included so that existing documents can be moved into the controlled environment.
Yes. Version control preserves the document history and supports authorised rollback to a previous version.
Yes. Review and approval routes can be configured according to document type, department, role and organisational requirements.
Yes. Audit trails record document actions, including changes, reviews, approvals, signatures and status updates.