Veton Ahmedi
Business Controller
Veton holds an MSc degree in Finance & Accounting and has over three years of experience working as an auditor and over one year as an accountant with very close collaboration in financial planning and analysis. Before joining Medidee, he worked for a few years as an auditor in well-known audit companies. More recently, he worked as a senior accountant at a multinational corporation in Switzerland, where he gained valuable financial knowledge. His strong accounting background and experience are important assets to the finance team at Medidee. Veton speaks English, German, Albanian and Macedonian.
DR Sebastian Augustin
Project Associate
Dr. Sebastian Augustin is a biologist by training and holds a Bachelor’s and Master’s degree from Heidelberg University. He holds a PhD in molecular biology and protein biochemistry from the University of Lausanne. Sebastian has 8 years of background in research, with broad experience in project design and management, as well as data analysis, scientific writing and science communication. At Medidee, he supports you with technical documentation for CE-marking, clinical evaluations for medical devices, performance evaluations for IVDs, as well as related regulatory aspects. Sebastian speaks fluently English and German and has a good understanding of French.
Anna Amovilli
Project Associate
Anna holds a M.Sc. in Biomedical Engineering from Politecnico di Milano and is specialized in Biomechanics and Biomaterials. Prior to joining Medidee, Anna worked in the research and development team of the University Hospital of Basel towards the clinical translation of bioreactor-generated tissue-engineered products.
With her academic background and professional experience, Anna supports you in setting up, conducting, monitoring and reporting clinical investigations. She is experienced with MDR-compliant technical documentation, QMS deployment and maintenance, as well as FDA 510(k) submission. Additionally, she supports clients to comply with EC/CH-REP obligations. Anna speaks fluently English and Italian.
Dr Silvia Anghel
Associate Director
Silvia Anghel developed a strong scientific research expertise in highly competitive and international laboratories in Canada and Switzerland, performing research in the fields of oncology, metabolism-related disorders, and gastroenterology.
She also acquired an industrial experience by working in different positions in the In Vitro Diagnostics (IVD) industry. Silvia managed various projects, including development, manufacturing, regulatory and quality and gained a valuable overview of the life cycle of a product from its development to its production and commercialization. Silvia is the Head of Medidee's IVD group, overseeing activities related to IVDR transition, and providing Regulatory and Performance Evaluation (PER) strategies. She helps you to determine the most appropriate (and pragmatic) regulatory pathway, to evaluate and improve your Technical Documentation, including evaluation of your analytical and clinical data, to deploy a QSR and/or ISO 13485 certified QMS and finally, she supports you throughout discussions with Competent Authorities and Notified Bodies. Silvia speaks French, English and Romanian.
Dr Linda Ahnen
Senior Consultant
Linda Ahnen is a physicist by training, specialized in biomedical engineering. Her doctorate at the ETH Zurich was carried out in close cooperation with the University Hospital Zurich, developing a novel near-infrared imaging device to image oxygenation in the brain of preterm infants. Linda is experienced in working, navigating, and managing interdisciplinary projects. She actively collaborates with experts from different fields and possesses proven scientific writing skills. Besides managing the Olten team, Linda supports you in clinical and regulatory strategies, is ready to evaluate and set-upTechnical Documentation, including Clinical Evaluations. Additionally, Linda supports you in set-up, coordination and management of Clinical Investigations and Usability Studies. Linda is fluent in German, English and has intermediate knowledge of Spanish.
Somashekara Koushik Ayalasomayajula
Senior Consultant
Somashekara Koushik Ayalasomayajula is a polymer engineer with 4+ years of experience within medical device industry in product development and quality & regulatory affairs. During his early career he focused on vascular/cardiovascular, oncology fields and also worked in projects concentrating on implantable devices, disposables and surgical technologies. With combination of technical background and his experience, Koushik is ready to provide support in trainings related to quality and regulatory affairs, deploying QMS according to ISO 13485, integrate MDSAP, GMP requirements and in the preparation of technical documentation of medical devices for global regulatory submissions (EU, MDSAP, ASEAN, South Korea, Argentina, South Africa and India). Being knowledgeable on IEC 27001 and DVG Act (Germany), Koushik can also support for ISMS implementation and approval of Digital health applications (DiGA). Koushik is fluent in English, Telugu, Hindi and has intermediate knowledge of German.