This past year, I set a personal goal to deepen my understanding of medical device regulations, specifically focusing on gaining hands-on experience in quality management systems. After searching for the right opportunity, I joined TR Equipment AB in Tranås, a company specialising in Class 1 medical devices—bathtubs, shower trolleys, and chairs, with a global distributor network.
Accepting this role meant temporarily relocating to my 1700 summer house in the Swedish forest, leaving behind my partner, my cat, and my best friend, Blixten the horse. While this decision came with sacrifices, I knew it was essential for advancing my career.
Facing New Challenges: An Food Drug Administration (FDA) Onsite Inspection
Early in my time at TR Equipment, I faced one of the most intense experiences of my career—a four-day onsite FDA inspection. The inspector, who travelled to Sweden specifically for this evaluation, put our compliance standards and my adaptability under pressure. Being relatively new to the team added an extra layer of challenge, but I embraced it as a learning opportunity. This inspection process proved invaluable, especially as TR Equipment was the only company in Sweden to receive an FDA onsite visit last year.
Certifications: ISO 9001, ISO 14001, and Working Towards ISO 13485
Another significant milestone was achieving successful certification visits for ISO 9001 and ISO 14001, reinforcing the company’s commitment to quality and environmental management. Navigating the requirements for these certifications was rewarding, and I gained a profound appreciation for the rigorous standards that guide our industry.
We also worked toward obtaining ISO 13485 certification, a crucial quality standard for medical device manufacturing. Participating in the audits for this certification was an incredible learning experience, providing me with insights into the stringent quality controls required to ensure patient safety. These certifications reflect TR Equipment’s dedication to excellence and the collective effort of everyone involved.
A Heartfelt Goodbye and Gratitude
Yesterday marked my last day at TR Equipment. Although it was a difficult decision, I felt it was time to return to my partner, my cat, and, of course, Blixten. This year has been an extraordinary journey of professional growth, and I am incredibly grateful to all my colleagues at TR Equipment. Their belief in me and unwavering support made every challenge feel like an opportunity. Thank you all for the encouragement, teamwork, and memories. I am so grateful to have been part of this team.
What’s Next?
As for what comes next—that’s yet to be seen. After a year of learning, growth, and stepping outside my comfort zone, I’m excited to see where this journey leads. I look forward to sharing new experiences and updates soon.
Thank you for following along, and here’s to whatever the future holds!
