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.

Illustration of compliance standards such as ISO 13485, ISO 14971 and IEC 62304

Compliance Standards

  • Quality & Risk Management – ISO 13485, ISO 14971
  • Software & Cybersecurity – IEC 62304, IEC 62443
  • Safety & Performance – IEC 60601, ISO 10993
  • Usability & Labelling – 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
Illustration of cloud, mobile, web and AI platform solutions
Illustration of software development across mobile, web and backend

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
Illustration of embedded systems and edge device design
Illustration of electronic hardware and PCB design

Hardware Design

  • Conceptualisation & 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)
Illustration of mechanical design, 3D modelling and prototyping
Illustration of risk management under ISO 14971

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
Illustration of biological evaluation and biocompatibility testing
Illustration of quality and regulatory compliance

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
Illustration of usability and human factors engineering
Illustration of the industry domains we serve

Domains

  • Medical Devices
  • US Health Plans
  • Education
  • Manufacturing
  • Supply Chain

IT Infrastructure

  • Server Setup
  • Server Migration
  • Cloud Migration
  • Virtualisation
  • Business Continuity Planning & Disaster Recovery
  • Database Administration
  • Hardening & Patching
  • Monitoring & Alert Automation
Illustration of IT infrastructure, cloud migration and disaster recovery