Revolve Healthcare

30/01/2026

📄 Clarity is the most critical factor in hospital software decisions.

Each decision affects patient safety, staff workflows and system stability. At the same time, budgets, integrations and regulations limit available options.

What often blocks progress is not technology itself.

It is the difficulty of making decisions in a complex, regulated environment.

This focus on clarity shaped our work on a national healthcare project with the Icelandic Directorate of Health.

👉 Read how we translated complex healthcare requirements into working software. Link in the comments.

28/01/2026

Pharma knows its regulations, processes and responsibilities. What it expects from technology partners is software that actually works in this reality.

Digital transformation in pharma is not about discovering complexity. It is about translating existing processes, data ownership and dependencies into reliable software architectures.

This is where many initiatives slow down.

Not because teams lack knowledge, but because software decisions fail to reflect how pharma truly operates.

Successful transformation happens when software is designed to absorb complexity. Clear architecture, integrations and long term maintainability make the difference.

That is the role technology partners must play in pharma. Not to explain regulations, but to deliver software that respects them by design.

👉 Read more about how digital transformation works in pharma https://revolve.healthcare/digital-transformation-pharma

26/01/2026

The week starts with important news.

Today, we are proud to announce the start of a new collaboration with MIV PSA.

MIV PSA is developing a specialised solution supporting TMJ diagnostics through advanced data analysis and visualisation. Such products demand not only clinical expertise, but also a mature approach to software lifecycle and quality.

Successful innovation happens when medical insight and software engineering evolve together. We are excited to begin working with the MIV PSA team and support the next phase of their product development.

Special thanks to Jakub Munk, CEO of MIV PSA, for the trust and open collaboration.

See how many healthcare projects we have delivered -> https://revolve.healthcare/projects

23/01/2026

💡 Your medical device deserves software that keeps it ahead.

We build, validate and maintain medical device software.

Our services include:

• mobile and desktop companion applications

• IoMT and cloud integrations (HL7 FHIR, secure APIs)

• cybersecurity, usability and regulatory compliance

We help manufacturers create connected, compliant and future-ready products that meet MDR, ISO 13485 and IEC 62304 standards.

👉Contact us to turn your device into a smarter, safer and market-ready solution.

Get in touch if you have any further questions about medical software development. We're happy to resolve any doubts!

20/01/2026

❗ Half of the places are already gone for a our small-group, closed Q&A session with TUV Nord auditors. Register to get the last spots.

Many founders assume that certification challenges start once the product is already built.

In reality, most MDR deadlocks begin much earlier, at the level of product classification, software decisions and the way technical documentation is structured from day one.

That is why we are hosting an online, closed, small-group Q&A session focused entirely on Software as a Medical Device, moving beyond theory and into real ex*****on.

During the session, we will cover two critical perspectives.

Przemek Grzywa, CEO at Revolve Healthcare, will walk through Software as a Medical Device from concept to certification, sharing practical lessons from working on four MDR products every year.

Katarzyna Doroszkiewicz and Małgorzata Gajek, auditors from TUV NORD Polska, will explain the most common critical errors in technical documentation that delay audits, from both technical and clinical trial perspectives.

The session is completely free of charge. Over half of the available seats are already taken, and attendance is capped to ensure a focused discussion, direct access to experts and meaningful Q&A.

Event details
Date: Wednesday, 28th of January 2026
Time: 2:00 pm to 3:30 pm (GMT+1)
Format: Online - limited availability, registration required

Are you confident that your current SaMD decisions will not lock you into months of avoidable regulatory delays?

Get one of the last spots here ->https://bit.ly/4a0BSYi

19/01/2026

Medical software punishes teams that treat it like a standard medical device project.

Most medical device manufacturers know regulations exist.
What often remains unclear is how deeply they affect software development itself.

Software is not hardware with code added on top. Its lifecycle, risk profile and validation logic behave differently from physical devices.

Standards such as MDR and software specific requirements shape architecture, development flow and long term maintainability. They are not documentation tasks that can be handled after development is done.

When software is planned and built with a hardware mindset, redesigns and delays become inevitable. This is why medical software requires a fundamentally different approach.

👉 Read more about medical software certification and development. Link in the comments.

16/01/2026

📉 Healthcare software fails when medical reality is underestimated.

Not because of code.
Because medical regulations are ignored.

After years of working with healthcare companies, one thing is clear. Technology built without understanding medical regulations eventually breaks.

At Revolve Healthcare, we see this every day. Healthcare is not a playground for quick MVPs.
It is a regulated, high risk environment where decisions have real consequences.

That is why we build differently.

We work with medical device companies, pharmaceutical providers and healthcare organisations and design software with regulations, safety and clinical workflows in mind from day one.

No retrofitting.
No last minute compliance panic.

Just software built for healthcare reality.

Do you see software failing because it ignores real medical workflows?
Are regulations treated as a burden instead of a design principle where you work?

Let’s talk about how healthcare software should really be built. Link in the comment.

15/01/2026

🚀Launching a is only the beginning.

Compliance doesn’t stop once your product is on the market.

With , post-market surveillance and CAPA are now critical parts of every device’s lifecycle. That’s why at Revolve Healthcare we make sure the software we deliver continues to meet these requirements.

We do not walk away once development is complete. We stay involved and support our clients long after the product goes live.

We help you:
• Monitor and analyse real-world data
• Manage technical CAPA processes (corrective and preventive actions by ) ,
• Keep your product traceable and safe

Our goal?

To help you stay compliant, not just get certified.

👉 Contact us to see how we can support your medical software through post-market compliance and beyond.

🔗 https://bit.ly/4rffhNF

13/01/2026

💬Traceability is the critical language regulatory specialists judge your product by.

From MDR and IVDR to FDA 21 CFR Part 820, ISO 13485, and IEC 62304 – every major framework in medical software development shares one word:
➡️ traceability.

Under MDR, notified bodies pay particular attention to the transparency of design decisions.
FDA 21 CFR 820 considers traceability a fundamental part of the quality management system.
ISO 14971 demands that risk control measures will be traceable from hazard identification to implementation and verification.

💡 In our latest article, we explore how traceability supports compliance with these standards. Check in the comments.

12/01/2026

🌍 Navigating regulations worldwide with MDSAP
ABAStroke is committed to making their SaMD app available to as many post-stroke patients as possible. To support this mission, we helped prepare them for an MDSAP (Medical Device Single Audit Programme) audit.

This approach allows compliance with multiple regulatory authorities through a single audit, simplifying the process while unlocking access to more countries for our client.

But that’s not all we did. We also supported ABAStroke through:
▪️ compiling with standards such as , , , ,
▪️ implementing a based on by cooperating with DevGoMed,
▪️ coordinating regular, once-per-spring risk management meetings,
▪️ maintaining the app during the clinical trials.

📖 Check out how we ensured compliance in this project: link in the comments.

27/06/2025

Healthcare systems talk — but do they truly understand each other? Meet the 4 levels of interoperability

(Healthcare Information and Management Systems Society) is an American organisation that aims to improve the quality of healthcare. They divide into four levels:

1️⃣ Foundational Interoperability
2️⃣ Structural Interoperability
3️⃣ Semantic Interoperability
4️⃣ Organisational Interoperability

What’s their aim? To make sure that you provide high-level data protection and privacy 🔒

🔗Do you want to learn more about those levels? Read our article: https://bit.ly/46jBIK7