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How to take a medical innovation to the market?

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Nejc Ludvik, head of quality and regulations at MESI, sheds light on that path

 Nejc Ludvik, head of quality and regulations at MESI.
Nejc Ludvik, head of quality and regulations at MESI.

We are proud to announce that MESI mTABLET TBI has just received the Food and Drug Administration (FDA) clearance to be marketed and sold in the US. The entire process took eight months to complete. The transformation from an innovation to a certified market product is a long but interesting process. Nejc Ludvik, head of quality and regulations at MESI, combines know-how on medical devices, IT, technology, standardisation and legal requirements on a daily basis.

Medical innovations are created all the time, but the approval of their market placement takes a lot of time and effort. Could you tell us a bit about that and your role at MESI?

To place a medical device on a certain market, MESI must ensure that the product complies with all local regulations and safety standards. My role is to first become very well familiar with the local legislation. I then lead the quality assurance team as we prepare all the documentation based on the local requirements. We also need to present the safety certificates proving that the device fulfils international safety standards.

All this is required to get a market license, e.g. the recent FDA clearance for the MESI mTABLET TBI in the United States. Preparing the documentation took about 3 months, with another 5 months of reviews and amendments. This is actually our second milestone of this kind; the MESI mTABLET ABI was FDA-cleared in 2020.

What are some of the essential criteria that MESI medical devices need to meet?

The most important criteria are definitely safety-related. We must ensure that MESI products are safe for use and operate as intended. We have to observe the highest international safety standards for medical devices in the development phase, and implement the world’s best practices and regulatory requirements into the finished product. That calls for very diverse knowledge on part of the team. Our products namely need some common, but also some particular standards depending on the type of the device (e.g. MESI mTABLET ECG vs. MESI mTABLET ABI).

The MESI company is very unique in the sense that it has the development, production, local sales and quality management on one premises. As a quality assurance team, we accompany the product from the start of its development to the end of its life cycle.

International standards not only hold for a device, but also for the company that produces it. Which ones does MESI comply with?

To produce a medical device in line with the highest standards, we must control all the processes throughout the company. MESI’s quality management system is certified under the ISO 9001:2015 and ISO 13485:2016 standards. We have also implemented all quality requirements from the Australian, Brazilian, Canadian, Japanese and US legislation, and obtained the MDSAP (Medical Device Single Audit Program) certificate. The various certifications that we hold have enabled MESI products to enter more than 50 markets.

A certification is not the end of the story. Market authorisations and standard compliance need to be maintained throughout the company and device’s lifecycle, and monitored through regular audits. What is the auditing process like for the MESI team?

Our team constantly monitors and reviews MESI processes, making sure that we comply with any legislation changes and the latest safety standards. Once a year, we perform an internal audit. This is when all our heads of departments examine all the processes at company level – along with the supporting documents and records. The main goal is to identify opportunities for improvement, and to recognise and eliminate potential issues with preventive measures.

To maintain the MESI quality management certificates, our quality management system is also reviewed by external auditing every year. We currently work with Slovenian SIQ (Slovenian Institute of Quality and Metrology) and DQS Medizinprodukte from Germany. The auditors hold very detailed interviews with our management and employees (e.g. those from production and development).

What are MESI’s plans for quality assurance in the future?

Our plan is to constantly improve our quality management system and implement solutions that will make our processes even more efficient. We also intend to obtain additional international certificates from information security and environment.

Enhanced processes result in enhanced quality of product and services. We want MESI to excel as a business partner and an innovation company synonymous with high-quality, easy-to-use products for our customers around the world.

MESI’s quality assurance team is quite ‘young’: how do you go about building such a team and what are your shared values?

Our company is now in the second decade of operation, which means that we have a quite a few years of experience. We constantly expand our know-how and are not afraid to tackle new challenges for further excellence. What makes us special and what are our values? I would say our team spirit, our eagerness to share knowledge with one another, and our dedication to MESI quality assurance. It truly is a pleasure working on new milestones in such supportive environment.