Driving patient empowerment
The Dawn Platform is highly specialized for regulated digital health products and compliance is woven through our entire ecosystem. With our modern, agile approach, we identify and address potential roadblocks to always lead with a patient-first approach. Through automations and pre-built foundational modules, our platform accelerates these fundamental components of digital health products for faster time to market.
A modular setup for accelerated delivery
Modules can be combined as needed for each individual product and these self-contained, compact modules allow for rapid delivery of robust, cutting-edge digital health products. This development structure enables granular life cycle management, optimizing overall impact assessment and testing of products.
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Agile Development
The Dawn Platform supports true agile development of regulated digital health products, allowing for fast, frequent release and continuous product updates.
Automated Processes
With automatic testing, documentation and deployment, we innovate and fast track complex development to get regulated products to market at speed.
Built-in Quality
With harmonized and standardized regulatory standards in the very foundations of our platform, we ease the road to compliance for any product.
Decision Support
We've developed innovative algorithms and building blocks to deliver support for progressive diseases, where complex decisions need to be made by the HCP such as dose escalation.
Excellence through our technologies
We’re made up of teams of experts and know firsthand the complexities that come with building and implementing regulated digital health products across multiple disease areas. We’re setup to deliver excellence at every stage, every time.
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Standards and certifications
Everyday at Dawn Health is underpinned by patient safety. Our solutions are developed and operate based on industry best practices, adhering to the following standards based on our pharma partners’ needs.
ISO 13485:2016
Quality Management for Medical Devices
This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry. Safety and quality are non-negotiable – that’s why Dawn Health is certified to 13485:2016.
ISO 14971 Application of Risk Management to Medical Devices
Risk Management is an integral part to Dawn Health Quality Management System. The standard describes the processes for identifying the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
IEC 62304 Medical Device Software Lifecycle Processes
Our quality management system implements IEC 62304 as a framework throughout the software life cycle processes.
ISO/IEC 27001 Information Security Management
Our information security management is based on the ISO 27001 principles and ensures the security of information assets whether in-house or entrusted to us by our customers.
GAMP5 A Risk-Based Approach to Compliant GxP Computerized System
ISPEs GAMP5 provides a product lifecycle framework and best practices for GxP critical computerized systems in the pharmaceutical industry. Our QMS leverages the ISO 13485, IEC 62304, ISO27001 and ISO 14971 standards to implements GAMP5.
IEC 82304 Health Software Product Safety
The standard applies to the safety and security of stand-alone health software products and points to ISO 14971 and IEC 62304 for risk and SW lifecycle processes. Applies to both MDSW and other health software products.
IEC 62366 Medical Device Usability
Relevant parts of the standard are used during risk management activities and UI/UX design.
UL-2900-2-1 Software Cybersecurity
This standard addresses cybersecurity for connected devices and Dawn Health follows this standard to address product specific cybersecurity risks. It is recommended to always take cybersecurity risks into consideration.