Epista helps Curoflow navigate MDR to register as Class 1 medical device

Curoflow gains competitive edge in medical device sector


Curoflow faced new regulations, a steep learning curve, and changing processes when registering a software as a Class 1 medical device under MDR.


The company successfully obtained Class 1 status under MDR while efficiently handling implementation, growth, and business process changes.

Curoflow is an intelligent, GDPR-secure, digital care platform that enables the health care sector to provide better and more efficient care. They’re one of Epista’s clients driving the innovations that improve health care around the world. Curoflow wanted to register their platform as a Medical Device under the new MDR (Medical Device Regulations). But they were not able to interpret the complex MDR requirements on their own. Epista provided the subject-matter expertise to achieve this goal and helped Curoflow to apply this knowledge to their business processes and future development.

Over the last few years, Sweden’s digital healthcare sector has experienced significant growth (International Trade Administration, 2021). This has increased competition for more traditional, in-person care. Curoflow’s goal is to support the changes in the industry by developing solutions and smart tools – like their registered communications platform – to help traditional healthcare providers to compete in the digital world.

“We develop smart solutions to enable the health care sector to provide better and more efficient care. We shorten the bridge between patient and care provider. Our products and services help the healthcare sector enter the new era of health care – digital healthcare.” - Shkar Hashmi, Head of Quality

To truly make an impact, Curoflow realized that they needed to register their solution as Medical Device. This step would differentiate them from their competitors and create an added level of trust among their customers. And they knew they needed more regulatory knowledge to achieve this ambition. Enter Epista. After meeting with the team, it became clear that Epista had the knowledge to interpret MDR, the experience to produce the necessary SOPs, and the professionalism to lead effective internal communication.

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Process and Project Methodology

Curoflow began the project by analyzing the market to understand where their company and product fit in among the competition. They found they needed to register as a Class I medical device. To do this, they needed to update their Quality Management System (QMS) – to establish their new policies and procedures – and implement a Document Management System for the management of the documentation in the QMS.

After deciding to go for an SaMD Class 1 registration under MDR, the team set timelines for the various project stages. For example, the timeline gave a deadline for a completed QMS by the beginning of June 2021, allowing time to create all the registration documentation in time for submission in July 2021.  

Each stage included regular meetings with the Epista team, Curoflow’s Quality Manager, and their CTO. In addition, the project regularly involved other business managers for progress checks. These meetings not only kept all relevant stakeholders up to speed, but also allowed for agility and adjustment as learnings were consistently being assessed as the project progressed.

“It was an active and agile process. The regular meetings allowed us to adapt the project and QMS as we developed it, so that it continued to meet our needs and goals as they changed over the course of the project.”

With goals and timelines set, Curoflow next needed to interpret and understand the guidelines and regulations required for its Class 1 registration. With Epista’s guidance, they were able to take the information from MDR and turn it into practical quality and procedural documents. In addition, a clearer understanding of the regulations guided them in structuring their existing processes and procedures, in practice.

Finally, with Epista’s guidance, Curoflow was prepared to take on the challenge of certifying their product as a medical device.



From the start, Curoflow knew that they wanted to register their solution as a Medical Device. However, they initially planned on registering under the existing MDD regulations. The switch to using MDR posed challenges. First, to determine the appropriate class, the FDA recommends identifying similar approved products to your own. This was a challenge because MDR is relatively new, so there are few approved products similar to Curoflow’s in the database. Second, MDR has many more requirements for Software as a Medical Device than MDD, which came into effect in 1993 – long before the International Medical Device Regulators Forum officially defined SaMD in 2013. And third, MDR can be difficult to understand in the context of your solution if you are not experienced in interpreting regulatory text.  

Yet sometimes, the risk is worth the reward. MDD would have been the easier choice in the moment, as companies that registered as MDD before May 26, 2021, can keep their classification until May 26, 2024.* But by challenging themselves to go for MDR, Curoflow set themselves up to have a competitive advantage over other digital health solutions.

“It would have been easier to go for the existing MDD regulation, but we wanted to be ahead of the curve. And, for Curoflow, that meant going for the new MDR regulation.”

Changing & Structuring Business Processes

It is always challenging to implement new routines and systems – especially in a rapidly growing company. For Curoflow, these changes included actions like implementing newly formulated SOPs and system changes with the software developers. Curoflow already had many best practices in place, the challenge came in documenting them.  

Curoflow already had many best practices in place - they just needed to document them and put them in their new QMS.


With teamwork, communication, and knowledge sharing, Curoflow submitted registration for their product as a Class I Medical Device. In addition to successfully completing the concrete goals of their project – implementing a QMS and submitting their product for registration – the team gained a wealth of knowledge that will help them as they continue their journey. This knowledge includes a variety of core skills to take with them into future solution, business, and personal development:

  • A more holistic understanding of quality
  • The ability to analyze current and future regulations
  • Best practices when producing and analyzing compliant documents

Critical Success Factors

Regular Progress Meetings

A good project will adapt as better processes and ways of working are uncovered. Success requires agility. During this project, Curoflow and Epista held weekly progress meetings to review the lessons learned. This helped them to steadily evolve over the course of the project rather than rely on radical changes later on.

Internal Communication

Good communication practices are also crucial for success. That’s why, from day one, the team at Curoflow made sure that all internal stakeholders were on board with the project. With new routines being presented and implemented every week, it was paramount that the details and scope were communicated clearly. Without this, it would have been even more difficult to make changes and execute new routines throughout the company.

Knowledge Sharing

The cornerstone of this project was the understanding and application of Medical Device Regulations. In this case, the Epista team used their regulatory knowledge to help Curoflow register their product. In addition to this, they made sure that the Curoflow team had a clear understanding of every detail of the project – such as how and why of interpreting the MDR guidelines and how to format and write SOPs. This ensured the formation of a knowledge base that Curoflow can take with them into future product certifications and QMS improvements.

Looking Ahead

Today Curoflow’s solution is registered as Software as a Medical Device under MDR, and their team has a better overall understanding of medical device regulations. This positions them to successfully develop their product portfolio with safe and secure solutions for the health care sector. They are now prepared to take on future regulatory changes, product development, and the improvement of their QMS.

Registering as a Class 1 device under MDR differentiates Curoflow in their sector. They have obtained a competitive edge in the eyes of the industry and created an environment of trust among their customers. Epista’s expertise helped Curoflow develop a company-wide quality mindset. They can now accurately convey the regulatory requirements in their SOPs and improve their business processes through the knowledge gained from their collaboration with Epista.

“It was really great and always fun to work with Epista. We just felt like we were adding value to our company (Curoflow) and to our work every time we had meetings. We are really happy with our work with Epista.” - Shkar Hashmi, Head of Quality

Are you ready to gain a competitive edge in the Life Science industry? Reach out. We'd love to chat about how we can help you make an impact.

*Footnote: After May 26, 2024, medical devices registered under MDD will have to re-register under MDR. 

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Robert Pettersson
Managing Director - Sweden

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