Improve your medical software development

Get this free ebook to enhance collaboration between software developers and regulatory specialists working under Medical Device Regulation.

Is this ebook for you?

You will find our content useful if you are:

  • a company owner seeking scalable and compliant software for the European market

  • a regulatory affairs specialist looking to collaborate effectively with technical teams

  • a software developer aiming to understand regulatory requirements

who works on medical software to be placed on the European market.

What will you learn?

  • Where to start with mixing Scrum methodologies with IEC 62304

  • How to enhance communication between developers and regulatory specialists for better teamwork

  • How to prepare documentation that meets Medical Device Regulation requirements without delays

  • Ways of encouraging developers to embrace documentation as part of their workflow

  • How to conduct a comprehensive risk analysis of your medical software aligned with ISO 14971

  • How to create an environment fostering knowledge-sharing

  • Avoid mistakes that could delay your product launch or result in costly penalties

Who are we?

We are Revolve Healthcare, an ISO 13485-certified software development company. We build more than medical software – we create legally compliant and scalable solutions.

We’ve spent two years creating an efficient software development process compliant with Medical Device Regulation, IEC 62304, IEC 62366, IEC 82304, and ISO 14971. We continuously improve our original approach, Scrum 62304, learning from our medical software projects.

In this ebook, we share strategies that have worked for us and our clients.

Now you can get a free copy of our ebook

on how to make your medical software effortlessly.

Meet some of the contributors

Łukasz Bandała, CTO & co-CEO of Revolve Healthcare

Małgorzata (Head of Regulatory) and I spent nearly two years developing our own agile software development process, which we internally named 'Scrum 62304', to ensure compliance with IEC 62304. We met once or twice a week, learning from each other – I had no knowledge of regulations, while Margaret had no background in software development. In the end, we successfully created a process that effectively bridges both worlds, and we continue to improve it with each subsequent MDR project.

Marta Danch-Wierzchowska, Project Leader at Revolve Healthcare

If you want the developers and regulatory to collaborate, you can lock them up in one room and wait until they start talking the same language. Or... you can make one team from them and treat the regulatory expert as every other team member joining daily standups and having its tasks. You will see the results from close cooperation very shortly.

Wojciech Ryczko, Technical Expert at Revolve Healthcare

We build compliant solutions, not just software. Our developers code with regulations in mind, creating comprehensive documentation that simplifies audits and protects investments. This approach turns compliance from a potential roadblock into a market credibility builder, avoiding penalties while ensuring everyone's on the same page. The result? Legally sound and functional software.

Wanda Sordoń, Regulatory Affairs Specialist at Revolve Healthcare

As regulatory specialists, we understand that developers might find the detailed documentation required by IEC 62304 tedious. They’re used to quickly solving problems and adapting, so documenting every step can seem like a hassle. Our job is to bridge this gap and show how thorough documentation benefits compliance and software quality.

Learn how to streamline collaboration

between developers and regulatory affairs specialists.