We consistently strive to enhance our QMS, ensuring alignment between our operational practices and legal obligations.
Anna Santaella Tortós-Sala joined itemedical last year to support the Quality Team to ensure compliance with EU Medical Device Regulations. Her primary focus is to optimize the Quality Management System (QMS) to ensure that our MediScore medical alarm solution is compliant, safe and effective. Her journey to itemedical was driven by her interest in innovative technologies and her desire to contribute to the medical field. With a background in Biotechnology and Neuroscience, she brings a broad experience into her role. And if you believe she spends her day studying regulations and requirements, you’re mistaken.
Itemedical: What are you doing as a Quality Officer?
“As a Quality Officer my main responsibility is to maintain and improve the QMS to ensure that it is compliant with the regulatory requirements, which means that our MediScore medical software solution, certified class IIb (CE 0344), is efficient and safe for the patient and that it performs as we intend to. We take our role as a medical software supplier seriously and consistently strive to enhance our QMS, ensuring alignment between our operational practices and legal obligations. Part of my job includes conducting audits and providing internal quality trainings.”
How did itemedical cross your path?
“I came across the job of Quality Officer on LinkedIn and it was ticking all my boxes, so I applied. I am passionate about innovative technologies and looked for a company which develops its own medial applications. Working together in a team towards ‘my own’ software solutions is what I missed in my previous role. I enjoy delving into the entire development process, discovering operational processes and finding out how they can be optimized. I am fascinated to see how all the knowledge gathered can both directly and indirectly help patients and healthcare professionals in the medical field.”
Can you briefly take us through your background so far?
“Of course. I was born in the north of Catalonia and I studied Biotechnology in Barcelona. Looking for an international experience and an interest of learning a new language, I was drawn to Germany for its innovative Biotechnology sector. Despite recommendations to move to Frankfurt, I preferred Berlin for its vibrant atmosphere. In Berlin, I worked as a laboratory technician in a neuroscience laboratory and as a freelancer writer at a company producing and exporting animal food additives. After that, I started a Master in Medical Neuroscience, which concluded with a thesis on Alzheimer’s Disease.”
And after your graduation?
“I initially wanted a PhD position in Alzheimer’s research, but couldn’t find one without animal testing, which I wanted to avoid. Eventually, I found a PhD project in Parkinson’s at Radboudumc, Nijmegen. After completing my PhD, I joined DADA Consultancy as a Junior Consultant Pharmacovigilance in the Benefit Risk Management team, where I conducted Post Market Surveillance (PMS) and Risk Management Plans for pharmaceutical companies; ensuring adherence to guidelines, managing risks and monitoring and detecting signals of adverse events.”
What is the greatest challenge in your new job?
“This position is entirely new to me and my primary challenge is identify areas for improvement. Understanding my colleagues work is crucial to generate valuable ideas to be compliant while in alignment with our itemedical DNA, so we don’t stress ourselves. Moving forward, I aim to improve our workflow and ensure that everybody comprehends the importance of adhering to our QMS.”
Why do you emphasize the importance of understanding and adhering to this QMS?
“Because if something happens in the high-care environment involving our medical software, it’s essential to track and trace, analyze and resolve the issue, maintaining patient safety and product efficiency. I realize that it could be tedious or it seems time-consuming for our team, but understanding this process is crucial.”
What may our customers expect from you and the Quality Team the coming year?
“Our customers may expect continued dedication from us to provide safe and efficient medical software solutions.”
What are you doing outside your work?
“I fly through the air 😊!” Not literally, but I do partner acrobatics, and I’m the one being thrown through the air. Besides, I have various hobbies like Pilates, dancing (Kizomba, Bachata, Salsa, Lindy Hop, etc.), bouldering and yoga. When I do not want to be active, I like to write and read.”