Please introduce yourself briefly.
My name is Palak Nama and I work at BYTEC as Regulatory Affairs Manager. In my role, I ensure that our medical devices and developments meet all regulatory requirements. I support the development department in areas such as risk classification, standards compliance, and documentation. Regulatory Affairs also works closely with Quality Management to ensure that our processes comply with ISO 13485 requirements.
How/why did you get into medical technology?
I have always been fascinated by the interface between medicine and technology. There are constantly exciting developments in these two dynamic worlds—and that is precisely what makes my work so varied. I find it particularly fascinating how technology today works so closely with people that it almost becomes part of the body or life. Many medical devices are not even consciously noticed in everyday life, even though they are enormously important.
What is the biggest challenge in your work and what challenges do you see for the future?
I currently see the biggest challenge in my field as being the constantly changing and new regulatory requirements and standards. You have to stay very alert to keep up to date—at the same time, you don't want to slow down projects or drag them out excessively. So you need to strike a good balance between flexibility and accuracy—that's exactly what makes my job so challenging.
Added to this is the balancing act between the drive for innovation and regulatory safety. Our customers want new products and fast market launches, but in the end, one thing always takes center stage: the safety of patients and users.
If you could decide for yourself, what kind of product would you develop/build?
I've thought about this for a long time—there's just so much happening in medical technology right now. My dream would be to create a digital ecosystem consisting of AI, wearables, and nanosensory implants. The goal: to detect diseases before they even cause symptoms. This would allow medicine to move beyond simply reacting to problems and start acting proactively.
This would, for example, avoid unnecessary visits to the doctor or allow treatments to be planned in a much more targeted manner. It would also significantly reduce the burden on the healthcare system – and patients would benefit from more individualized, preventive care.
If you could have a superpower, what would it be and why?
If I could have a superpower, I would “cheat” a little—I would like to be able to choose it depending on the situation. In an audit or in a discussion with colleagues, mind reading would certainly be helpful—it would make many things more efficient.
And if I felt like a good glass of wine in the evening, I would simply teleport myself to Tuscany and enjoy the sunset there.
What do you like most about your job?
What I like most about my job is the feeling of doing something truly meaningful. I know that may sound like a typical answer for someone who works in medical technology—but that's exactly what it is: we develop and produce solutions that often didn't exist before, and in doing so, we help people. This awareness gives my work a special meaning.
The standards and regulations help to ensure that our products are safe and reliable. And that motivates me: I'm not only helping patients, but also our developers to be able to implement their ideas in the first place – so that innovations can be created that really make a difference.
What makes BYTEC a great place to work?
For me, BYTEC is an employer that fosters an open and supportive working atmosphere. Here, I have the opportunity to develop both professionally and personally. The diversity of the projects constantly challenges and encourages me—each one brings new requirements and its own standards.
I find it particularly motivating that our work creates real added value for people. At BYTEC, I can combine my personal development with meaningful work—for me, that's the ideal combination.
How would you describe our team in three words?
Curious, solution-oriented, and team-oriented
