bluesBrackets - Medical Device Software Development Services

Custom Medical

Software

UX
SaaS

Empowering Healthtech with High-Impact Medical Software

bluesBrackets empowers ambitious healthtech companies with advanced applications for medical diagnostics, cloud-based SaaS, and intuitive medical UX, bridging technical excellence with regulatory standards for business value.

Technologies Powering Medical Device Software

Bluetooth
STM32
NRF

End-to-End Services for Regulatory-Compliant Medical Software

From FDA-compliant development to embedded Bluetooth expertise and user-centric healthcare interfaces, we deliver solutions that drive faster approvals, enhance patient experience, and establish lasting value.

Truly appreciated

I'm overly excited about our project and the nice progress we're making. With this progess I feel quite convinced we'll complete the products in time. Thanks for your hard work and dedication. Truly appreciated 👍Egil B.A. - Hearing aid company

Reliable Partner

Based on our experience so far, we can assure that this is a reliable partner, making informed and appropriate decisions, and operating in accordance with the latest standards.Agnieszka K.Alloweat - a dietary startup

We Value Professional Relationships

We are happy to recommend working with Blues Brackets because we highly value their professional relationships and their ability to act responsibly, systematically, quickly, and accurately.Tomek R.NAOKKO - a furniture industry startup

Attention to Detail

With this letter, I would like to provide a reference for Blues Brackets for their diligent and committed work on projects that were completed with attention to the smallest details and admirable punctuality.Michał B.Codelab - software house

Business-Focused Medical UX and Scalable SaaS Development

Our medical UX specialists create accessible interfaces for clinicians and patients, while our team engineers regulatory-ready SaaS for diagnostics, monitoring, and EHR interoperability—tailored to your unique business.

Regulatory-Ready Medical Device Software Development

Secure, scalable applications for medical devices, fully compliant with MDR, FDA, and ISO 13485 standards. We embed regulatory best practices into design, documentation, and testing, reducing compliance risks from day one.

Custom Medical Applications for Diagnostics and Monitoring

Tailored solutions supporting diagnostics, remote monitoring, and patient data management across all platforms. Our custom development ensures interoperability, data protection, and a seamless user experience.

Cloud-Native Medical SaaS and Interoperability

Develop scalable SaaS platforms designed for interoperability and regulatory assurance. Integrate EHRs, HL7/FHIR, and connected IoT systems to eliminate data silos and boost operational efficiency.

Healthcare UX & UI Design Specialists

Intuitive, accessible interfaces created for clinicians and patients. Guided by best practices and rigorous usability testing, our UX team enhances workflow efficiency and patient trust.

Embedded & IoT Integration for Connected Medical Devices

Advanced integration of Bluetooth, STM32, and NRF platforms enables real-time monitoring, diagnostics, and wearable devices—accelerating innovation across embedded medical systems.

Transparent, Cost-Efficient Software Delivery

Leverage Poland’s deep tech talent for up to 30% lower costs than Western EU, maintaining uncompromised standards in quality, documentation, and project transparency for every healthcare client.

Why Choose bluesBrackets for Medical Software?

Compliance Without Compromise

Every bluesBrackets project is engineered for regulatory success—adhering to HIPAA, GDPR, FDA, and MDR. We guide you from concept to certification, ensuring code, documentation, and processes meet the latest standards.

Accelerate Time-to-Market for Healthcare Innovators

Our agile delivery enables rapid prototyping and fast, regulatory-ready releases. Whether you are a medical startup or an established vendor, we help you secure approvals and commercial success without delay.

Deep Technical and Domain Expertise

From Bluetooth (BLE), STM32, and NRF-based embedded systems to full-stack medical SaaS platforms, our engineers combine clinical insight with technical mastery for every healthtech project.

Proven Use Cases: Certified Medical SaaS at Scale

Our work with major EU hospitals includes scalable, cloud-based medical SaaS that achieved certification ahead of schedule and realized 30% operational cost savings for stakeholders.

Case Study

We increase efficiency and solve key business problems by creating advanced technological solutions tailored to your needs.

Student listening to a lecture using a device supporting hard of hearing children with BLE Audio

Embedded

BLE Audio for better learning access

We supported Audinor, a company developing innovative hearing aid technologies, in building a BLE Audio device for hard of hearing children. The solution helps improve classroom communication and equal access to education in schools and kindergartens through cutting-edge wireless audio transmission.

Jun 22, 2024 — 7 min read

View of the airport terminal with passenger check-in counters

Automation

App for managing tourist transport

We helped Mr. Shuttle, a professional tour operator, build an application for managing tourist and business transport services. The solution supports airport transfers, intercity routes, and day trips — improving logistics and client experience in the travel industry.

Nov 20, 2023 — 6 min read

Client Success: Certified Medical SaaS for Leading EU Hospital

A major EU hospital group partnered with bluesBrackets to deliver an FDA-compliant, cloud-based medical SaaS platform. Leveraging our embedded systems and UX expertise, we ensured scalable, interoperable results and reduced operational costs by 30%.

How do you ensure regulatory compliance in medical device software development?
Our experts embed regulatory best practices—FDA, MDR, ISO 13485—into every phase of software design, documentation, and testing. We guide clients through compliance from concept to certification.
What is your experience with Bluetooth and embedded systems for medical applications?
We specialize in custom Bluetooth (BLE), STM32, and NRF-based solutions for real-time monitoring, diagnostics, and wearable medical devices, addressing technical and regulatory complexities in each project.
How long does it take to build a medical SaaS platform?
Timelines vary by scope, but our agile approach enables MVP delivery in as little as 3–4 months, with built-in compliance validation and scalability options to meet evolving requirements.
Why consider a Polish software house for medical software development?
Working with a Polish software house offers EU-aligned compliance, up to 30% cost savings, and access to deep technical expertise, making your medical software development efficient and reliable.
What case studies demonstrate your success with medical device software?
We delivered a certified, cloud-based medical SaaS platform for a leading EU hospital network, achieving regulatory approval ahead of schedule and helping the client reduce operational costs by 30%.

Ready to Build Medical Software with Confidence?

Contact bluesBrackets for a tailored consultation on medical device software, custom SaaS, or advanced healthcare UX. Achieve regulatory-approved, future-ready solutions for startups and healthcare organizations worldwide.

At Blues Brackets we solve real business challenges with the latest and proven technology.

Let's talk

<mail>hello@bluesbrackets.com

<phone>+48 535 462 678

Let's meet

Kraków, PolandWrocław, PolandWarszawa, Poland

Contact

Blues Brackets sp. z o. o.NIP 8842824071REGON 527681035