Interested in starting your own entrepreneurial journey but unsure what to expect? Then read up on our interview with Richard Houlihan, CEO of EirMed Ltd., located in Sofia, Bulgaria.

What's your business, and who are your customers?

EirMed provides EUDAMED training and data submission software to help MedTech companies comply with the European Commission(EC) Medical Device Regulation (MDR/IVDR) requirement to populate the EC database EUDAMED with medical device data.

EUDAMED is full of complexities with 100s of data rules. We take the client data, validate it, prepare it, convert it to the required XML and deliver it to EUDAMED. The software we provide makes the process a lot easier and a lot cheaper for client companies than if they created their own systems.

Our training saves companies weeks of research by giving them an in-depth understanding of the complexities of EUDAMED. As is the leading site for EUDAMED assistance, we also provide ongoing support and consultancy.

Tell us about yourself

My background is in IT software development, and I have over 28 years of experience in the business. I was working for the European Commission on an IT project managing Eudamed 2, an earlier incarnation of the software MedTech companies are now tasked with using. I became aware very quickly when watching the regulations being drafted and hearing from the competent authorities that these regulations and the new EUDAMED were both going to cause a lot of confusion and problems in the industry. So in 2012, I decided that I was going to help with a EUDAMED consultancy.

The confusion that the industry is currently faced with makes it easy to be motivated. On a regular day, we receive many emails from companies just lost with the documentation the EC provides, and we enjoy helping them. We not only help them with their confusion but also with strategies for EUDAMED, both for getting their data in there and managing it in the future.

What's your biggest accomplishment as a business owner?

Keeping clients happy and knowledgeable on any and all changes in EUDAMED. We have been running this business now for nearly four years, and on a regular basis, you feel a real sense of accomplishment when clients leave very happy with their submissions and improved understanding of EUDAMED.

What's one of the hardest things that come with being a business owner?

Competing priorities is the hardest part. We are constantly updating our software with new functionalities, both ideas and client requests which is great; however, sometimes you have to push back and say we will implement it but not straight away. Also, when looking at new regulatory markets, we would love to cover all just now, but we can't; you have to take each one on its own merits and prioritize which comes first. This can be frustrating because, as I said, you would love to be able to do it all straight away.

What are the top tips you'd give to anyone looking to start, run and grow a business today?

  1. Do not just talk about doing it; take the first steps and do it. Ideas are brilliant, the implementation of ideas is what counts.
  2. Do not underestimate the reach of social media, even the free unpaid ads that you put up yourself. Make sure you do it regularly. Building a brand is all about being out there all the time.
  3. Have fun, don't be afraid to try. If what you are doing is stressful, that's ok; however, if that stress takes over your life and impacts your family, then you need to take a step back and reassess your priorities. There is no point in being hugely successful if you have nobody to share it with, so have fun and enjoy the journey. If you fail, so what? Try something new, and learn from the experience.

Where can people find you and your business?


If you like what you've read here and have your own story as a solo or small business entrepreneur that you'd like to share, then please answer these interview questions. We'd love to feature your journey on these pages.

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