industries

Healthcare

Improving healthcare through innovative technologies and digital solutions that enhance access to data, improve efficiency, and help people live better.

See our work in action

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Innovative medical management platform launches streamlined mobile app experience with medical hardware for FDA approval.
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Creating a custom Stripe-powered POS mobile app to integrate with Ritual’s eCommerce system.

Client recognition

We have experience submitting 510k applications to the FDA, specifically for Software as a Medical Device (SaMD). Rely on our knowledge to prepare, manage, and streamline the application process.
From EMR and EHR integrations to managing PHI, we can consult, build, and manage compliant health solutions. We can help set up HIPAA compliant hosting environments on AWS and PaaS platforms.

We know what it takes

FDA 501(k) approval experience

We have experience submitting 510k applications to the FDA, specifically for Software as a Medical Device (SaMD). Rely on our knowledge to prepare, manage, and streamline the application process.

HIPAA compliant solutions

From EMR and EHR integrations to managing PHI, we can consult, build, and manage compliant health solutions. We can help set up HIPAA compliant hosting environments on AWS and PaaS platforms.

Our expertise

Connected medical devices

Headway designs and develops software that powers connected MedTech solutions that are both industry-compliant and meet your customers' needs. We have partnerships with RA/QA experts to ensure your solution meets the necessary compliance requirements.

Trusted partnerships

Our close partnerships with electrical device and hardware experts include SaMD design and development, MedTech go-to-market launches, GPO navigation and approved vendor status for hospitals, and software-enabled disposable device design.

Simplifying the complex

Our designers and developers have the experience and ability to resolve complex challenges to deliver remarkable patient and provider experiences. Lean into our proven process and approach to creating impactful solutions to the market quickly and effectively.

client testimonial
"From beginning to end, top to bottom, Headway has not only taken on every aspect of software development for our latest standalone mobile app product, but has done so with great organization, strategic thinking, and attention to detail."

Joscelyn Daguna

Biosensor Launch Lead at One Drop

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