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Dawn Health PACE - MDSW/SAMD SaaS

by Dawn Health A/S

Modular development of Regulated Digital Health Products

Digital therapies are impacting every health condition today, creating many breakthrough treatments. To reinforce the process of designing future digital therapy platforms, Dawn Health has built PACE (Platform for Applied Care Ecosystems) —a streamlined platform that modularizes and standardizes MDSW (medical device software) development across web- and mobile products.

Our MDSW-Qualified modules can be compiled to serve your exact needs without requiring custom development. Allowing for significant savings, fast time-to-market, a predictable product development process and a submission-ready technical file.

SaMD/MDSW Platform with pre-built Quality Assurance Documentation

Dawn Health’s PACE provides an ecosystem of digital health features that are MDSW-qualified, secure, and curated, resulting in a more efficient development process with higher quality features. It also enables Dawn Health to help deliver accelerated development processes for regulated software compliant with applicable standards for MDSW/SAMD development: ISO 13485, IEC/ISO 82304, IEC/ISO 62304, and ISO 14971.

Key Benefits of PACE

Reduced Project Costs

Pre-built and MDSW-qualified software modules ensure a lowered total project cost and a more predictable product development process.

PACE to Products

Pre-built, MDSW-qualified software modules ensure a fast time-to-market allowing you to make important learnings about d health products early.

Standardized Delivery Model

The PACE Platform and its components ensure a product development process with a proven modus operandi for product development, reducing risk of re-work and creating a direct pathway to medical device submission.

New Product Features

Opting-in on the PACE ecosystem means that your digital health product stays up to date with the expectations of patients and that data can continuously be exchanged with other industry-leading healthcare ecosystems.
PACE-based products can choose to opt-in for new features and integrations on-demand. You only pay for the features you use.

First-class Microsoft Azure citizen

Our partnership with Microsoft Azure means that you will enjoy the capabilities and technologies of a leading Cloud provider, while your digital health product stays compliant with MDSW/SAMD design and development regulations through PACE’s MDSW-qualification.

New ecosystem integrations

As new integrations are developed for PACE-based products, you will be able to leverage a wider range of use for your data – including integrations with EHR/EMR systems, and identity integrations – ensuring that your product is seamlessly integrated into the ecosystems of healthcare.

Upgrade on the fly

Add new features on-the-fly and pay only for what you need. The PACE platform allows you to opt-in for new features with a single click. This ensures flexibility throughout the development and product lifecycle, which will help you to deliver high-quality solutions relevant to your end-users.
With our MDSW-qualified PACE modules, your product can be upgraded to MDSW-grade at any time. Try out your digital health products with a low initial commitment, and upgrade to MDSW-grade once you have proven your concept.

Reduced Maintenance Costs

Using standardized MDSW-qualified software modules in your digital health products effectively reduces maintenance costs and ensures that you stay compliant with regulatory requirements for cybersecurity, privacy and safety.


Leverage real-time insights across all PACE products

Since PACE enables collection of standardized metrics they are also comparable with ample room for product specific measurements. This means that you can access key performance metrics for all your digital health products in real-time.
Analytics across every product enable product performance transparency and provide valuable insights into the performance and usage of each app as well across your app ecosystem.
These valuable insights can be leveraged across all PACE products. While ensuring anonymity across solutions, the insights, gathered by Dawn Health, can identify improvement opportunities for your product that could increase user adoption, retention and satisfaction. This will help you in creating valuable products which will ultimately benefit users.

At a glance

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