For device makers
The app that goes with your device, built under your design controls.
Cater builds patient and clinician apps for device setup, readings, trends and follow-up. Each release comes with requirements, test evidence and development records for your design file. You own the custom software and hold the source.
What we build
- Patient apps. iPhone, Android and web access for setup, pairing, readings and trends.
- Clinician tools. Review readings, create follow-up tasks and send agreed data to the clinic’s record system.
- App-store publishing. Prepare listings and submissions, respond to review questions and publish through your developer accounts.
Firmware, device algorithms and clinical evidence stay with your team.
cater.mccauley.io/for-device-manufacturers#records
Documentation with each release
- Requirements and architecture.
- Test evidence traced to the requirements.
- Third-party components.
- Known defects.
Software life-cycle records follow IEC 62304. We contribute the software portions of your ISO 14971 risk-management file and IEC 62366-1 usability file.
We work as a qualified supplier within your quality system. You receive source code, change notices and audit access. Core and custom-software releases follow your change control and include their development records.
Your regulatory team holds the submission and licensing responsibility. We prepare software evidence for your Health Canada application and amendments, and support the software documentation for other submissions your team leads.
Your app and its source code
The listing, app and messages carry your name. You own the custom work and hold a permanent licence to the Cater core in your deployment, with the complete source available to your team.
User data is hosted in Canada and can be exported. Your branded trust and privacy centre explains data use, hosting, security, service providers, AI where used, accessibility and privacy requests.
Support for the life of the product
The annual licence covers fixes, releases and testing against operating-system updates. Changes pass through your design controls. Your team holds the source if you bring maintenance in-house.
With the patient’s permission, readings can be shared with Apple Health and Health Connect, as well as the clinician’s record system through an agreed interface.
English and French are included, with additional languages and right-to-left layouts available. Organizational SSO serves staff; patients can use Google or Apple. Interfaces follow WCAG 2.2 AA, with device and browser support defined for the product.
Add 24/7 human phone and in-app chat support under your name for app setup, sign-in and navigation. Device and clinical questions go to your designated teams.
See a reading reach the care team
A fictional home monitor. The patient pairs it, takes a reading and views the trend. An out-of-range reading creates a follow-up task. “See what the clinic sees” opens that task and a simulated record-system update.
Interactive product preview. The device and readings are simulated; this is not a licensed medical device.
Cost and next steps
Regulated work is quoted for the app, documentation, verification and validation it requires. The quote separates the build fee from the annual maintenance licence.
Send your supplier questionnaire or ask about a requirement. We’ll involve your engineering, quality and regulatory teams in the scope.