Digital Medical Devices

Many organizations are well on their way to embracing connected, new digital business models, that require substantial changes in IT systems and technologies currently used. Medical industry, like its counterparts, is not an exception to this trend and the digital transformation taking place.

Global cost pressures in the healthcare ecosystem are forcing medical companies to innovate faster than ever before. Simultaneously, safety requirements and performance standards are becoming more and more rigorous. The surge of digital data, automation of processes, interconnectedness of systems and a widespread use of mobile devices have created an ominous set of digital challenges for medical companies.

OUR APPROACH

During more than 15 years of experience in medical software development services to the healthcare industry, Comtrade has acquired a unique domain expertise and applied reliable software development methodologies, aligned with IEC 62304, within either agile or the traditional waterfall model.

AGILE APPROACH

Over the years, we have successfully developed software for medical devices (firmware), healthcare IT systems, as well as mHealth solutions. We partner with our customers to drive advancements in medical IT technologies by leveraging our cross-industry expertise. Our expertise in processes, technology, execution and management of medical software projects ensures that software is designed and built to meet rigorous safety medical software development standards of the healthcare industry.

HOW YOU BENEFIT

01

Reduce the risk and costs

02

Shorten Time-To-Market

03

Innovate faster

04

Embrace the latest technologies

05

Build secure and reliable solution

06

Keep your core expertise

07

Meet strict safety and regulatory requirements

SOFTWARE ENGINEERING SERVICES

Requirements engineering
Configuration management
Design and architecture
Implementation
Verification and validation
Support and maintenance
Project management

PROJECTS

New product development
Prototypes and concepts
Platform migration
Product lifecycle extension
Support and maintenance
Independent V&V services

EXPERIENCE

Remote data managers (ECG viewer, POC data manager)
Healthcare IT solutions (primary healthcare IS, ePrescriptions)
Medical devices (blood gas analyzer, CPR device, patient monitor, defibrillator)
Telehealth systems (remote ECG monitor, video care system, remote access to doctors)
mHealth solutions (mobile based diagnostics, education platform, connected health platform)
POC connectivity (HL7, ASTM, POCT1-A2, ISO/IEEE 11073)

STANDARDS

We use software development methodology that is fully compliant with regulatory requirements and safety standards of the medical industry.

IEC 62304

ISO 14971

EN 62366

Resources