Software Engineering

Electrical Engineering

Engineering Services

Industrial Engineering

Mechanical Engineering

Wearables

Remote Patient Monitoring

Cardiac Sensors

Cloud/Mobile Applications

PRODUCT EXPERTISE

Regulatory Compliance

Verification and Validation

Pre‐clinical & Clinical testing

Rapid Prototypes

TESTING EXPERTISE

Maximize your medical device investment by taking advantage of the Contex Edge

CONTEX is an ISO 13485 certified company and offers to its customers, expert industry knowledge and engineering services to help deliver medical devices to Canadian and global markets with the assurance of “on-time” and “on-budget” delivery.

Our ‘concept -to- market’ approach focuses on providing both turn-key and contract engineering services to assist companies in avoiding costly mistakes and to help deliver medical devices that are safe, reliable, and profitable. Our team of qualified engineers and industry professionals will ensure that your Class I- I-III medical device development life–cycle is as stress-free as possible while assisting you with crucial regulatory submissions.

Technical Expertise

Concept to Market Approach

We can help you define your medical device concept.

At this stage, whether you have a need for a medical device or a concept to provide technology—our industry experts will bring your ideas to life.

  • Providing You with Product Definition and Feasibility
  • Defining Your Market and Product Requirements
  • Developing Your Regulatory & Marketing Strategy
  • Developing Your Regulatory Plan, IP Plan, and Business Case

Product Expertise

Our Innovative Solutions

Cardiology/Cardiac Sensors

CONTEX has extensive experience in cardiology, particularly in the development of advanced cardiac sensors/monitors. CONTEX’s experience includes the development of Holter, Event, Extended Event, and Mobile Cardiac Telemetry monitors and body sensors.

Remote Patient Monitoring

CONTEX has previously developed compliant Health Care Platforms for use in Remote Patient Monitoring. This includes experience with both mobile technology/apps, custom IoT transmitters, in addition to the development of backend software used to access patient data. CONTEX has developed technology for real time patient vitals monitoring featuring optional Telepresence support.

Cloud-Based Software/Analytics

CONTEX has extensive experience in the development of Cloud and Web Based applications.  This includes experience with the development of Analysis Software utilizing Artificial Intelligence for the post processing of health data for diagnosing and reporting of detected medical disease.

Wearables

CONTEX has extensive experience in the development of long use wearable body sensors.  This includes the certification with the FDA and experience with Biocompatibility testing to the ISO 10993 standard.

Emergency
Rescue Devices

CONTEX has experience in the labelling, packaging, registration, and distribution of Emergency Rescue Devices such as the LifeVac Anti-Choking device.