Product Development

HealthTech Solutions
Medical Devices, IVDs, Scientific Instruments, Wearables, ...

Ideation & Proof of Concept

• Feasibility Studies and Research

• Market Research & Competitor Analysis

• Business Model & Value Proposition

• Requirements Analysis & Capture

• User Requirements Specification & System Design
  

Design & Development

• Medical Devices, In-Vitro Diagnostics, Well-Being Devices, ...

• Wearables, BioSensors and Health Monitors

• Scientific Instruments and Control Systems

• Electronics, Firmware, Software, App

• Design for Reliability (DFR)

• Design for Manufacture (DFM)

• SaMD and Cloud-Based Applications
  

Design for Compliance

• Design & Development to ISO13485 Requirements

• Safety and Essential Performance (60601/80601/61010 series)

• Risk Management (14971)

• Software Lifecycle Processes (62304)

• Verification & Validation Planning and Testing