Thermoregulation
Respiratory Support
Consumables
NICUÂ Support Systems
About Us
Quality You Can Trust. Safety You Can Depend On.
At nice Neötech, quality is not a department — it’s our DNA.
Every product we design, assemble, and deliver is backed by high-level regulatory compliance, rigorous testing, and clinical safety validation.
ISO Standards
Standard/ Regulation
Purpose
ISO 9001
Quality Management System
ISO 13485
Medical Device Quality Management & Regulatory Compliance
ISO 14971
Risk Management for Medical Devices
IEC 60601-1
International Electrical Safety Standards for Medical Equipment
IEC 60601-1-2
Electromagnetic Compatibility (EMC) Compliance
EU MDR (2017/745)
European Medical Device Regulation — Safety, Clinical & Post-Market Requirements
CE Marking
European Conformity for Safety, Performance & Quality
CDSCO (India)
Central Drugs Standard Control Organization — Indian Medical Device Regulatory Approval
How We Ensure Quality
In-house design & component manufacturing.
Multi-stage 100% functional testing.
Precision calibration & safety checks.
EMI/EMC & electrical safety compliance.
Design verification & risk evaluation.
ISO & CE standard quality monitoring.
In-house design & component manufacturing
Multi-stage 100% functional testing
Precision calibration & safety checks
EMI/EMC & electrical safety compliance
Design verification & risk evaluation
ISO & CE standard quality monitoring
Key Highlights
Built Under Certified Quality Systems
ISO 9001 & ISO 13485-driven processes, ensuring traceability, documentation, and regulatory control at every stage.
QMS (Quality Management System) Driven Operations
End-to-end quality governance — from design, risk analysis, prototyping, validation, manufacturing, packaging, and post-market surveillance.
Design Control & Risk Management
ISO 14971-based risk evaluation, usability testing, and failure mode analysis (FMEA) for every device.
Safety-First Engineering
IEC 60601-1 and IEC 60601-1-2 compliant — protecting against electrical hazards, EMI/EMC interference, and operational risks.
Performance, Durability & Reliability Testing
Continuous load testing, stress testing, endurance testing, and calibration verification for sustained performance.
Traceability & Documentation
Every unit is tracked with serial identification, production logs, quality records, and service traceability.
Regulatory-Approved Manufacturing
CDSCO-approved facility with cleanroom standards, calibration-certified equipment, and documented SOP workflows.
User-Centric Clinical Validation
Designed with real feedback from neonatologists, nurses, respiratory therapists, and biomedical engineers.
Post-Market Surveillance & Vigilance
Continuous monitoring, feedback loops, and corrective & preventive action (CAPA) to improve performance in real-world conditions.
Ethical & Sustainable Manufacturing
Environmentally responsible waste management, safe material usage, RoHS considerations, and responsible sourcing.
Key Highlights
Built Under Certified Quality Systems
ISO 9001 & ISO 13485-driven processes, ensuring traceability, documentation, and regulatory control at every stage.
QMS (Quality Management System) Driven Operations
End-to-end quality governance — from design, risk analysis, prototyping, validation, manufacturing, packaging, and post-market surveillance.
Ethical & Sustainable Manufacturing
Environmentally responsible waste management, safe material usage, RoHS considerations, and responsible sourcing.
Design Control & Risk Management
ISO 14971-based risk evaluation, usability testing, and failure mode analysis (FMEA) for every device.
Safety-First Engineering
IEC 60601-1 and IEC 60601-1-2 compliant — protecting against electrical hazards, EMI/EMC interference, and operational risks.
Performance, Durability & Reliability Testing
Continuous load testing, stress testing, endurance testing, and calibration verification for sustained performance.
Traceability & Documentation
Every unit is tracked with serial identification, production logs, quality records, and service traceability.
Regulatory-Approved Manufacturing
CDSCO-approved facility with cleanroom standards, calibration-certified equipment, and documented SOP workflows.
User-Centric Clinical Validation
Designed with real feedback from neonatologists, nurses, respiratory therapists, and biomedical engineers.
Post-Market Surveillance & Vigilance
Continuous monitoring, feedback loops, and corrective & preventive action (CAPA) to improve performance in real-world conditions.
Galleries
ISO 14971
Risk management for medical devices.
ISO 11195
Anaesthetic & respiratory equipment — pharmacological agents.
ISO 10651-5
Lung ventilators — requirements for infant respiratory apparatus.
ISO 80601-2-74
Respiratory humidifiers — safety & essential performance.
ISO 5367
Anaesthetic & respiratory equipment — conical connectors.
ISO 5356
Anaesthetic & respiratory equipment — conical connectors for airway systems.
ISO 10993
Biological evaluation of medical devices.
ISO 18562-1
Biocompatibility evaluation of breathing gas pathways.
IEC 60601-1
Medical electrical equipment — general safety & essential performance.
IEC 60601-1-2
Electromagnetic compatibility requirements.
IEC 60601-1-8
Alarms & essential performance requirements.
IEC 60601-2-19
Infant incubators — particular requirements.
IEC 60601-2-20
Infant resuscitators — particular requirements.
IEC 60601-2-21
Suction equipment — particular requirements.
IEC 60601-2-50
Oxygen concentrators — particular requirements.
IEC 60601-1-12
Home healthcare medical equipment & systems
IEC 60601-1-6
Usability / ergonomics — general safety & performance.
IEC 62633
Interoperability of neonatal & pediatric medical devices.
EN 62304
Medical device software — software lifecycle processes.
EN ISO 15223-1
Symbols for medical device labels, labelling & supplied information.
EN 1041
Manufacturer information to be supplied with medical devices.
EN 62304
Software lifecycle for medical devices (overlaps ISO/IEC requirements).
ISO 14971
Risk management for medical devices.
ISO 11195
Anaesthetic & respiratory equipment — pharmacological agents
ISO 10651-5
Lung ventilators — requirements for infant respiratory apparatus
ISO 80601-2-74
Respiratory humidifiers — safety & essential performance
ISO 5367
Anaesthetic & respiratory equipment — conical connectors
ISO 5356
Anaesthetic & respiratory equipment — conical connectors for airway systems
ISO 10993
Biological evaluation of medical devices
ISO 18562-1
Biocompatibility evaluation of breathing gas pathways
IEC 60601-1
Medical electrical equipment — general safety & essential performance.
IEC 60601-1-2
Electromagnetic compatibility requirements.
IEC 60601-1-8
Alarms & essential performance requirements.
IEC 60601-2-19
Infant incubators — particular requirements.
IEC 60601-2-20
Infant resuscitators — particular requirements.
IEC 60601-2-21
Suction equipment — particular requirements.
IEC 60601-2-50
Oxygen concentrators — particular requirements.
IEC 60601-1-12
Home healthcare medical equipment & systems.
IEC 60601-1-6
Usability / ergonomics — general safety & performance.
IEC 62633
Interoperability of neonatal & pediatric medical devices.
EN 62304
Medical device software — software lifecycle processes.
EN ISO 15223-1
Symbols for medical device labels, labelling & supplied information.
EN 1041
Manufacturer information to be supplied with medical devices.
EN 62304
Software lifecycle for medical devices (overlaps ISO/IEC requirements).
© 2025 nice Neotech Medical Systems Pvt. Ltd.,
All Rights Reserved Other Trademarks are the property of their respective owners. The information on this webpage is intended for healthcare professional only
© 2025 nice Neotech Medical Systems Pvt. Ltd.,
All Rights Reserved Other Trademarks are the property of their respective owners. The information on this webpage is intended for healthcare professional only