SOFMEDICA GROUP, a pioneering company that has revolutionized the healthcare systems in Europe over the last 28 years

Mihai-Alexandru Cristea 19/12/2022 | 09:00

SOFMEDICA GROUP is one of the few healthcare providers in Southeast Europe that has flourished through the turbulent and unregulated 1990’s, introducing high-end medical technologies and ensuring early and accurate diagnosis with minimal impact on patients’ lives. Over the years, the company has gone through tremendous challenges, contributing to a well-developed health infrastructure by consolidating an essential link between patients, medical facilities, and healthcare professionals. As people make the difference between an average and an exceptional organization, we sat down today with Cristina Grigorescu (CFO) and Cristina Miroescu (Compliance Director), two visionary leaders of SOFMEDICA GROUP.

Cristina Grigorescu, CFO (left), and Cristina Miroescu, Compliance Director (right), on Quality Management System, Business Innovation, and Learning Ecosystem


What is the status of the group today in terms of business and geographic coverage? Which businesses are mature and solid, and which are still in the start-up mode?

Cristina Grigorescu: There have been several stages until now. The 1994 to 2005 interval represents the foundation of the Group. From the very beginning, we aimed at building a strong culture as well as at consolidating a substantial base for business development, long-term compliance, and economical sustainability.

Romania marks our debut in MedTech distribution, partnering with key producers in Dialysis, Surgical, and Cardiovascular Care. Therefore, we have initiated a considerable number of medical premiers such as the introduction of automatic peritoneal dialysis therapy in Romania, the initiation of the “Artificial Heart” program in Southeast Europe (SEE), the first robotic-assisted surgery program in SEE, and the first capsule video-endoscopy in the SEE.

Despite the challenging macroeconomic environment, we were among the first companies to expand the activity outside Romania, opening the second office in Greece. At present, SOFMEDICA Group operates in five countries (Romania, Greece, Hungary, Bulgaria, and Cyprus), and by the end of the year, we are planning to also add Croatia to the map. Additionally, Serbia represents a potential market in the future. With a team of more than 200 professionals at group level, we developed 5 major business lines, all in the healthcare field, creating a complete and complex ecosystem equally appreciated by customers, authorities, partners, and patients. Through our integrated services, we aim at creating a broad medical infrastructure that benefits from innovative technologies, exceptional healthcare facilities, solutions for medical operational leasing, and a comprehensive learning ecosystem.

ISLE Academy (Innovation, Simulation & Learning Ecosystem) plays a pivotal role in our culture, designed to provide hard and soft skills to healthcare professionals, assuring a meeting point for the most innovative life-saving technologies and an optimal environment for simulation, online training, and e-learning.

EMERALD Medical Center offers customized healthcare services, being specialized in cardiovascular and neurological conditions.

MEDCITY (The Medical Mall) is essential in developing high-end infrastructure, specially designed to host healthcare providers according to the latest building standards and operating regulations. Simultaneously, MEDI LEASING offers solutions for operational leasing, facilitating innovative medical programs.

Last but not the least, SOFMEDICA provides life-saving and minimally invasive technologies aimed at revolutionizing the way medical professionals operate. Our technologies are crucial to the well-functioning and innovation of the health system, being essential in curing life-threatening conditions such as several types of cancer or neurodegenerative diseases.

By reaching a level of 60 million Euros turnover, the activities of SOFMEDICA GROUP have achieved various stages of maturity. Over the past 28 years, the Group has created a solid and sustainable business culture, being ready for regional expansion. EMERALD, the youngest company of the Group, has developed a successful business model in healthcare services through an integrated and multidisciplinary approach. This year, EMERALD also aims at expanding to other areas in Romania, integrating genetics and oncology to its medical portfolio.

In this way, we create a robust business model by exploiting synergies not only between technologies or specialties within each activity, but through the power of such synergy, between the group’s activities and between countries. Right now, we have developed a model that can be successfully replicated in multiple countries and received in a positive way by stakeholders in each new territory.


What is “the secret sauce” that allowed your group to expand into five business lines and five EU countries? Were you expecting and planning for this to happen twenty-plus years ago?

Cristina Grigorescu: We often receive this question, and we are delighted to offer our perspective. We focus on innovation, constant investment, novel approaches, and the implementation of life-changing technologies that can benefit both patients and healthcare professionals. Two key pillars of our organization are sustainability and continuity, backed up by our compliance processes that keep our standards high. Simultaneously, our strong financial capacity plays a pivotal role in our business development.

Additionally, we build on the long-term and prepare for the next 20 years by considering all the healthcare trends and the progress of medicine. For instance, 25 years ago, we were a team of 20 members, and we were investing one million Euros in Romania; however, 10 years later, we added new countries to the map and numerous other activities to our business portfolio. Currently, we are optimistically discussing about investment plans of 100 million Euros and the expansion to two other countries in the region in 2022 and 2023.


How did your Financial, Quality and Compliance governance influence your business? Positively and negatively?

Cristina Grigorescu: We invest in a sustainable way, focusing on our core activities and healthcare innovation. We have developed a financial discipline while ensuring a balance between identifying and seizing opportunities within an ambitious time horizon. We also ensure long-term sustainability, providing a development platform for all five areas of interest. Despite several macroeconomic challenges, we discovered the secret key to success by reinvesting profits each year and harnessing the efforts of our banking and business partners.


What is the group vision for the next 28 years and could you share some sneak peek into your business plans for 2023/2025?

Cristina Grigorescu: As healthcare is evolving exponentially, at an unimaginable pace, we aim at expanding our businesses to all countries in the ‘New Europe’ region and remaining a major learning ecosystem for our strategic business partners. We will stay on the innovation side of healthcare, by digitalizing and trying to implement artificial intelligence in our business practice. Continuity is another word that defines our culture; therefore, we continue to invest in the new generations. All these aspects will consolidate our position within the healthcare sector, making a difference for patients, customers, authorities, partners and for our team and their families.


Further on, we will discuss with Cristina Miroescu, Compliance Director of SOFMEDICA Group about the role of a Quality Management System for a sustainable and safe business practice.


How did your Financial, Quality and Compliance governance influence your business?

Cristina Miroescu: Investing in implementing and maintaining financial, quality and compliance governance and informatics systems is costly in the short-term; however, in the long term, all these investments and efforts pay back as they shape our company culture, enhance company reputation and clients’ confidence for consistently delivering reliable, safe, and performant medical technology. We believe that any successful business should have a clear vision, as well as a strategic leadership approach and a solid foundation of human values such as ethics, integrity, hard work and passion. The combination of all these contributed to sustainable development and our 28 years of growth is mainly due to following these principles in a systematic manner within the frame of quality and compliance systems in which we have invested considerable resources throughout all these years.


Would you recommend other non-public Cos invest in such governance, systems, and policies? Which are the benefits they should expect and when? And which are the challenges and obstacles they need to be prepared for?

Cristina Miroescu: Definitely, yes! We encourage all the economic operators to invest in implementing and maintain management systems, governance systems and compliance policies. It is challenging and may seem pricey, indeed, however, there is no other way to exist as a sustainable and reliable business entity without these. If we analyze the medical sector, the investment costs are constantly growing, so are the ones for upgrading the systems, infrastructure, policies and procedures that need to be followed. We operate in a highly regulated environment where all economic operators must ensure transparent practices and comply with the applicable safety and performance requirements. There are voices in organizations stating that a quality management system is increasing bureaucracy. From our first-hand experience, we can say that this is a valid perception during the initial stages of maturity that unfortunately could last a couple of years before the entire organization understands that the quality management system contributes to the consolidation of a culture where everyone understands the “why’s”. Why do we follow the standards, why do we have so many procedures, why is audit indispensable, and ultimately, why are our quality and business objectives inseparable? The past 28 years reconfirmed that our quality management system is crucial not only for our business development but for the internal system of equity and transparency that has shaped our image on the healthcare market, as well.


Which were the highest moments of pride in your career? Which were the biggest challenges you had to face? How did you overcome them?

Cristina Miroescu: Just like anyone else in this industry, I started from the bottom line and of course, it was not an easy journey; however, I always felt that the organization I am part of is investing in team members, creating endless growth opportunities for them. My story starts in the spring of 2003 when I was assigned to implement ISO 9001 at SOFMEDICA. In this way, I learned about ISO 9001 for the first time, and I understood that we had an incredibly tight timeline to get certified. The audit day was just around the corner, and I felt that everyone was pointing fingers at me for the poor readiness. At the end of the audit visit, the auditor mentioned: “I recommend the certification as a goodwill gesture for a young organization under the commitment that you will improve by next year”.  However, at that time, the system was far from perfect. In the following years, we went through annual audits and endless reports. I still remember my frustration that despite making a huge effort, we still hadn’t succeeded to make the system start working. Step by step, year by year, people were gradually starting to follow the procedures. After obtaining our first certification, SOFMEDICA opened legal entities in different other countries and gradually, each entity obtained the ISO 9001 certification.

Later on, we took the strategic decision to align all the legal entity under the same quality management system.  That was the moment when we started harmonizing all our processes for all SOFMEDICA entities. Just one year later we obtained our first group certificate, ISO 9001:2015, for all legal entities under the SOFMEDICA name. This represented our tipping point that reconfirmed our mission to meet customers’ expectations and consolidate the power of synergy among all our team members in The New Europe. The next years some other important milestones followed, such as the implementation of the EU MDR requirements and the ISO 14001 implementation. After several months of meetings and internal struggles, we successfully passed the certification audit and received the certificate after another six months. We are ISO 13485 certified now by an MDR designated Notified Body which represents an incredible performance, and a great milestone on the SOFMEDICA map as this is a state-of-the-art QMS specifically designed for medical devices.



A leading company with a connected organizational culture, SOFMEDICA delivers exceptional results since 1994, providing both patients and medical practitioners with innovative and life-saving solutions. The group is defined by collaborative leadership and solid ethics, two essential qualities harnessed by Cristina Grigorescu (CFO) and Cristina Miroescu (Compliance Director).

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