OUR CAPABILITIES

Healthcare & Life Sciences

NeoTech accelerates innovation in Healthcare & Life Sciences through FDA/ISO-compliant engineering, embedded systems development, regulatory consulting, and digital health solutions. We support global medical device manufacturers, diagnostics companies, healthcare providers, and digital health innovators with end-to-end product development, compliance, and lifecycle services

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Mechanical Design

We design and engineer mechanically robust, safe, and production-ready medical devices that meet global regulatory requirements.

Conceptual and detailed mechanical design for Class I, II & III devices
3D modeling, CAD development, GD&T, tolerance analysis
Design for manufacturing (DFM) & assembly (DFA)
Material selection for biocompatibility & sterilization (ISO 10993)
Finite Element Analysis (FEA) for stress, fatigue, and thermal behavior
Human factors engineering (HFE/Usability per IEC 62366)
Design optimization for injection molding, machining, casting & 3D printing

Electronics & Embedded Software

We develop compliant, safe, and high-performance electronics and embedded software that power next-gen medical devices.

PCB design, analog/digital circuitry, sensor integration
Embedded firmware (C/C++), RTOS-based development
Wireless communication (BLE, Wi-Fi, NFC) for connected devices
Device control algorithms & safety interlocks
Power management for portable & wearable medical devices
IoT enablement & secure cloud connectivity
Compliance with IEC 60601, IEC 62304, ISO 14708 standards

Quality Assurance, QMS & Data Integration

We strengthen quality, safety, and compliance through robust quality management systems and validated data workflows.

QMS implementation aligned to ISO 13485, 21 CFR Part 820
CAPA, NCR, SCAR, and complaint management
Supplier quality management & audit support
ERP/MES/QMS/LIMS integration for end-to-end transparency
Data integrity compliance (ALCOA+ principles)
Validation of processes, equipment, utilities, and software (CSV)
Risk management frameworks per ISO 14971

Regulatory Affairs Consulting

We support manufacturers across the complete regulatory lifecycle — from documentation to global market entry.

Regulatory strategy & pathway mapping (FDA, CE, MHRA, TGA)
510(k), PMA, De Novo, CE Technical Files creation
Design History File (DHF), Device Master Record (DMR), Device History Record (DHR)
Clinical evaluation reports, labeling reviews & UDI submissions
Gap analysis, audit preparation & remediation
Post-market surveillance (PMS, PSUR, PMCF)

Software Quality Assurance

Ensuring medical software meets the highest levels of reliability, accuracy, and regulatory compliance.

Verification & Validation (V&V) of medical software
Test plan, test case development & requirements traceability
Automated testing for mobile, cloud & embedded systems
Risk-based testing aligned to IEC 62304
Cybersecurity testing for connected medical devices
Usability testing, performance testing & interoperability testing

Quality Remediation & Compliance Verification

Helping organizations address gaps, streamline compliance, and resolve regulatory observations.

FDA warning letter & 483 remediation
CAPA system redesign & effectiveness checks
Process remediation for manufacturing, quality, and documentation
GAP assessments for ISO 13485, 21 CFR Part 11 & Part 820
Internal audit readiness and mock audits
Risk management file updates & remediation (ISO 14971)
Verification of compliance for legacy or acquired devices

Remote Patient Monitoring Apps

Building secure, scalable digital health platforms for hospitals, MedTech startups, and telehealth providers.

RPM app development for chronic care, vitals monitoring & diagnostics
Integration with BLE-enabled medical devices
AI/ML analytics for predictive insights
HIPAA/GDPR-compliant architecture & secure health data exchange
EHR/EMR interoperability using HL7/FHIR standards
Alert systems, dashboards & clinician portals
Cloud-based remote monitoring frameworks

Technical Publications

We create precise, compliant, and easy-to-understand documentation essential for healthcare professionals, regulatory bodies, and end users.

User manuals, service manuals & installation guides
Clinical and technical documentation for regulatory submissions
eIFU (electronic Instructions for Use)
Maintenance guides, troubleshooting documents, illustrated parts lists
Training materials for technicians and medical staff
Compliance with ISO/IEC documentation standards
Multi-format delivery (PDF, HTML5, multimedia, AR/VR support)

Ready to Engineer Tomorrow’s Vehicles?

Let’s co-create solutions that drive performance, innovation, and sustainable growth.

Partner with a team that understands your challenges and delivers results that matter

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