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
Woman confused on the various medical device regulatory standards.
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.
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
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.
Source: mHealth Developer Economics

The Solution

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
Build and update a Medical App anytime, anywhere with our no-code platform.
Using the solution's no-code platform, patient-centric health apps can be created in minutes, not months.
Quality Management System
ISO 13485 compliant 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
User confused from a poor user experience with a Medical App.
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

Customers

We work with world-renowned healthcare institutions and industry-leaders in Pharma and MedTech.
clinician, doctor, healthcare professional, principle investigator wanting to build a Medical App.

Healthcare

Enhance a patient journey by providing them with personalised care on their mobile phone.
pharma, principle investigator or CRO wanting to build a Medical App.

Pharma

Accelerate Drug Development by building a mobile-based companion study for Phase II-IV clinical trials.
MedTech wanting to build a Medical App

MedTech

Provide a more holistic care offering by providing a companion app for your medical device.

It's time to put your ideas into action.

Would you like to deliver new standards of care using medical-grade patient-centric software without the complexity?

Contact Us