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.