Medical Device Software Development

Safe, reliable, and compliant software that meets your needs

Software Development

CriTech starts with a high-level set of system or software requirements for a product and creates safe, reliable, and compliant software that meets your specifications. During development, our project management plan and regular status reports provide visibility into each of the activities required for successful software development. At every phase of the project, our critical software development process provides detailed guidance for our engineers on all development activities including:

Software Development

Verification

Cybersecurity Risk Management

Software Risk Management

Project Management

Software Quality Assurance

Software Configuration Management

Developing programmer Team Development Website design and coding technologies working in software company office
Female UX Architect Has Discussion with Male Design Engineer, They Work on Mobile Application Late at Night, She Drinks Coffee. In the Background Wall with Project Sticky Notes and Other Studio Employees.

Requirements Traceability

Traceability is a critical work product in any software project or system which is often missing in legacy systems.  Our team creates traceability matrices as part of a project’s deliverables.  The gaps identified by the effort are instrumental in finding problems with both documentation and in the software itself.  We provide solutions with any problems we encounter.

Communications Development

Good communication is essential. We provide communications solutions for a variety of protocols, including Health Level 7 (HL7) - used for both hospital information systems (HIS) and laboratory information systems (LIS) - as well as:

Controller Area Network (CAN)

Ethernet

Bluetooth™

Other Serial (USB, RS-232/485)

Proprietary Networks

Medical technology network team meeting concept. Doctor hand working with smart phone modern digital tablet and laptop computer with graphics chart interface, with virtual icon diagram

We look forward to talking with you!

We are ready to assist in getting your medical device software compliant and can start at any point during your life cycle process!