Alexandra is passionate about improving people’s lives through software. While developing software in the healthcare sector has become more challenging due to increased regulatory demands, this shouldn’t hold back enterprises from creating exceptional software products . With our experience and knowledge we can help businesses navigate the regulatory landscape and minimise cost by doing it right the first time.

A little about Alexandra

 

Alexandra began her career in consumer electronics, but ever since she managed her first medical software product, she realised that making a positive impact on people’s lives was what she wanted to keep doing. Although regulatory affairs were not a burning passion of hers in the beginning, over the years she became an expert in aligning agile processes with regulatory requirements, so that team can make product that are better and safer. Alexandra excels in coaching agile teams, helping them understand the purpose behind their actions.

 

Highlights 

  • Over 10 years experience as Product Owner for Software as a Medical Device in the areas of prenatal diagnostics, drug safety, telemonitoring, and patient apps for the management of chronic or acute diseases.
  • Introduced Scrum and coached agile teams in several companies that make products in regulated environments.
  • Experienced in designing the risk management process according to DIN EN ISO 14971
  • PSPO II (scrum.org), PSM I (scrum.org)
  • Dipl.-Inform. (TUM), Dr. rer.nat. (TUM), MBA (Henley Business School)

Q&A

q.: what do they say about you?

a.: Highly logical and analytical, but at the same time very passionate about her projects.

q.: what do you love most about your job?

a.: It demands a super broad set of skills: technical, regulatory, usability, medical, business. I interact with very diverse people (patients, healthcare professionals, regulatory professionals, developers, C-level executives) with very different problems, and being able to help them is extremely satisfying.

q.: If you had a super power what would it be?

a.: When I join a new project or company, I’m very quick to grasp the fundamentals of the domain, analyse the technical and organisational challenges and make a positive and lasting contribution.

q.: what useless information stuck in your head since uni time?

a.: First order logic is complete and consistent.

“(…) I want to put a special emphasis on the fact that, while keeping the regulatory requirements (GxP) in mind, she always questioned the complexity of their implementation in our processes, (…)”