Our Expertise
The following reflects where our deepest expertise sits. It doesn’t mean it’s the only work we take on, see Services for the full picture.
Compliance Standards
- Quality & Risk Management – ISO 13485, ISO 14971
- Software & Cybersecurity – IEC 62304, IEC 62443
- Safety & Performance – IEC 60601, ISO 10993
- Usability & Labeling – IEC 62366, ISO 15223, ISO 20417
- Regional Regulatory Pathways – EU MDR, FDA 21 CFR 820/QMSR, MDSAP
Platform Solutions
- Cloud / Cloud First
- Mobile / Mobile First
- Web
- Desktop
- Embedded / IoT
- Cross Platform
- AI / ML
- Enterprise Applications
Software Development
- 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 Design
- 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
- 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
- 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)
Risk Management
- Risk Management Planning
- Risk Analysis, Evaluation and Control under ISO 14971
- Risk Management Review
- Production and Post-Production Activities
- Documentation and Records
Biological Evaluation
- Biological Evaluation Planning, Reporting
- Bio-compatibility Testing Strategy under ISO 10993-1:2018
- Drafting responses to regulatory queries regarding product bio-compatibility
Quality & Regulatory
- 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
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
Domains
- Medical Devices
- US Health Plans
- Education
- Manufacturing
- Supply Chain
IT Infrastructure
- Server Setup
- Server Migration
- Cloud Migration
- Virtulization
- Business Continuity Planning & Disaster Recovery
- Database Administration
- Hardening & Patching
- Monitoring & Alert Automation
