Remove the complexity and accelerate time-to-market in
getting your Health App FDA Approved and CE Marked
Through our Digital Health App Builder Plus solution.
A regulatory storm is coming for health apps...
Rigorous safety standards apply to everyday medical devices like a Stethoscope.
Why shouldn’t rigorous safety standards apply to health apps to ensure that the quality of information being presented to our loved ones is clinically sound and correct?
This safety concern will be addressed in the EU in May 2021 when EU Medical Device Regulation (MDR) becomes effective. MDR will have a major impact on Digital Health.
MDR will enforce any health app on the EU market that is interventional to be medical-grade and therefore classified as a software-as-a-medical-device with a notified regulatory body.
Remember the chaos caused when GDPR was introduced in May 2018?
MDR will make GDPR look like a walk in the park in comparison for health apps.
The Problem
Building medical-grade Health Apps is hard.
Achieving medical-grade is complex
It requires a regulatory consultant, a Quality Management System to create and maintain medical device history records and so much more.
Building medical-grade health apps are expensive.
It costs on average €425,000 as it requires an interdisciplinary team, a secure storage solution for patient data and a medical-grade infrastructure.
Medical-grade Health Apps are time-consuming to build
Takes on average 15 months as it's a highly-regulated industry. Stringent security and medical device regulation need to be taken into consideration.
Digital Health App Builder Plus removes the complexity and reduces the time-to-market in getting your Health App FDA Approved and CE Marked by 1 year.
No-code Platform
Using the solution's no-code platform, patient-centric health apps can be created in minutes, not months.
Quality Management System
Our Quality Management System provides quality records for the health app which can be leveraged for medical-device classification. Saving you at least 12 months in getting your solution to market.
Content Management System
Digital Health App Builder Plus's intuitive Content Management System allows you to create care plans, engage with patients, gain insights and customise your health app instantly.
Digital Health App Builder Plus is compliant with medical device regulatory standards ISO 13485 and IEC 62304. We are FDA Approval and EU MDR ready.
Platform Features
Our platform has a broad range of medical-grade building blocks to cater for your digital therapeutic needs.
The Patient receives a clinic-branded companion mobile application that helps businesses in a variety of medical fields to improve the patient experience, from the initial point of contact to long-term follow-up.
Personlised Care Plans
Smart Surveys
Wearable Integration & Physical Assessments (e.g. 6 min walk test)
Co-develop. Engage. Incentivize. Monitor. Optimise. Deliver a better patient experience.
The clinic accesses Zendra's Admin Dashboard to customize versions of the Patient App for both iOS and Android.
The Admin Dashboard is a software application that allows businesses in a variety of medical fields to configure and monitor the Patient App for its patients.
App Builder
Care Plan Management
Telehealth
Patient & Care Team Management
Analytics
Marketing Campaign Management
Highly-interoperable. Designed to seamlessly integrate with healthcare systems.
Rest Assured that our platform will integrate in nicely to your existing Health Systems.
All Health Data in our platform is stored using the highly-interoperable HL7® FHIR® standard.
Medical-grade. Built for medical device classification.
Patient safety comes first. Unlike 98% of software companies worldwide, Zendra implements medical-grade Quality Assurance on all our processes, procedures, and Usability Engineering to ensure your product meets it's Intended Use.
Zendra carefully selects Suppliers and tools upon undertaking stringent vetting and validation.
Zendra is compliant with medical device regulatory standards ISO 13485:2016, IEC/DIS 62304:2018 and 21 CFR Part 11 compliance.
Zendra Health provides quality records and regulatory documents as part of each project deliverable which can be leveraged by clients for medical device classification of a digital therapeutic.
Secure-by-design infrastructure.
Security is paramount in any software business, particularly when it comes to storing patient data.
Zendra Health’s data store is GDPR & HIPAA compliant and uses best-in-class security measures for storing personal health information.
All server communication is encrypted over TLS and data is encrypted on REST.
Our platform securely stores patient data so you can concentrate on what matters most, delivering better outcomes for your patients and your clinic.
Our platform has a broad range of medical-grade building blocks to cater for your digital therapeutic needs.
Patient View
Engage. Incentivise. Improve health outcomes.
The Patient receives a clinic-branded companion mobile application that helps businesses in a variety of medical fields to improve the patient experience, from the initial point of contact to long-term follow-up.
Co-develop. Engage. Incentivize. Monitor. Optimise. Deliver a better patient experience.
The clinic accesses Zendra's Admin Dashboard to customize versions of the Patient App for both iOS and Android.
App Builder
Care Plan Management
Telehealth
Patient & Care Team Management
Analytics
Marketing Campaign Management
Regulatory
Medical-grade. Built for medical device classification.
Patient safety comes first. Unlike 98% of software companies worldwide, Zendra implements medical-grade Quality Assurance on all our processes, procedures, and Usability Engineering to ensure your product meets it's Intended Use.
Zendra carefully selects Suppliers and tools upon undertaking stringent vetting and validation.
Zendra is compliant with medical device regulatory standards ISO 13485:2016, IEC/DIS 62304:2018 and 21 CFR Part 11 compliance.
Zendra Health provides quality records and regulatory documents as part of each project deliverable which can be leveraged by clients for medical device classification of a digital therapeutic.
Interoperability
Highly-interoperable. Designed to seamlessly integrate with healthcare systems.
Rest Assured that our platform will integrate in nicely to your existing Health Systems.
All Health Data in our platform is stored using the highly-interoperable HL7® FHIR® standard.
Security
Secure-by-design infrastructure.
Security is paramount in any software business, particularly when it comes to storing patient data.
Zendra Health’s data store is GDPR & HIPAA compliant and uses best-in-class security measures for storing personal health information.
All server communication is encrypted over TLS and data is encrypted on REST.
Our platform securely stores patient data so you can concentrate on what matters most, delivering better outcomes for your patients and your clinic.
Customers
We work with world-renowned healthcare institutions and industry-leaders in Pharma and MedTech.
Healthcare
Enhance a patient journey by providing them with personalised care on their mobile phone.
Pharma
Accelerate Drug Development by building a mobile-based companion study for Phase II-IV clinical trials.
MedTech
Provide a more holistic care offering by providing a companion app for your medical device.