Our Expertise

Compliance Standards like ISO 13485, ISO 14971, IEC 62304, IEC 60601, ISO 10993

Standards

ISO 13485
ISO 14971
IEC 62304
IEC 60601
ISO 10993
IEC 62366
ISO 15223
ISO 20417

Platforms Solutions on Cloud, Mobile, Web, Deskto, Embedded/IoT, AI / ML applications

Platform Solutions

Cloud / Cloud First
Mobile / Mobile First
Web
Desktop
Embedded / IoT
Cross Platform
AI / ML
Enterprise Applications

Custom Software Development on Android / iOS, Front-End, Full Stack, Database, Business Intelligence

Software

iOS / Android
BI Reporting
Frontend
- HTML / CSS / Angular / React / Vue.js
Backend / Desktop
- Node.js / Python / Java / C# / C++
Databases
- Relational - MySQL / Microsoft SQL Server
- NoSQL Databases - MongoDB / Cassandra
- Cloud-Native - DynamoDB / Cloud Spanner / Cosmos DB
Emerging - Graph / Time-Series / Serverless

Embedded System Support for Hardware Agnostic Design, Prototyping, Edge Devices, Embedded GPUs, SoCs

Embedded Systems

Platform Selection
Prototyping
Edge Devices
Embedded GPUs
Linux based SOCs
Hardware Agnostic Design
Model / Bare Metal / RTOS based design
Hardware / Software in Loop
Sustenance Migration

Hardware Design Support Schematics, Circuit Design, Layered PCBs, Prototypes, CAPA, RCA, Remediation

Hardware Design

Conceptualization & Feasibility
Schematic & Circuit Design
Multi Layered PCB Layout & Design
Prototyping & Testing
Manufacturing Support
Post-Design Support
CAPA, RCA, Remediation Support
Reverse Engineering
Sustaining Engineering (Discontinuance, Obsolescence)

Mechanical Design support for 3D Modelling, Simulations, Prototypes, Material, PLM, PDM

Mechanical Design

New Product Design
3D Modelling and Simulations
Rapid Prototyping & Additive Manufacturing
Material Selection and Assessment
PLM & PDM Services
CAPA, RCA, Remediation Support
Re-engineering
Sustaining Engineering (Discontinuance, Obsolescence)

Systems support for Risk Management, Human Factors, Usability Validation, Post-Market Surveillance

Usability & Human Factors

Early Stage Research and Planning
Formative Usability Studies
Risk Management Support
Human Factors Engineering (HFE) Documentation
Summative Usability Validation
Design Input and Review
Training Development Support
Post-Market Surveillance

Biological Evaluation Planning, Reporting, Testing Strategy under ISO 10993-1:2018

Biological Evaluation

Biological Evaluation Planning, Reporting
Bio-compatibility Testing Strategy under ISO 10993-1:2018
Drafting responses to regulatory queries regarding product bio-compatibility

Risk Management Planning, Analysis, Evaluation, Control under ISO 14971

Risk Assessment

Risk Management Planning
Risk Analysis, Evaluation and Control under ISO 14971
Risk Management Review
Production and Post-Production Activities
Documentation and Records

Quality & Regulatory Compliance (QA / RA)

Product Classification and Registration
Regulatory Compliance
Quality System Compliance
Regulatory Strategy Development
Documentation Management
Post-Market Surveillance
Regulatory Training and Support
Quality Management System (QMS) Maintenance
Product Quality Control
Risk Management
Quality Assurance
Quality Compliance

Domains like Medical Devices, Insurance, US Health Plans, Education, Manufacturing, Supply Chain

Domains

Medical Devices
Insurance
US Health Plans
Education
Manufacturing
Supply Chain

IT & Infrastructure

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