Verena Wieser has been working with medical devices for 10 years and specialises in Software as a Medical Device (SaMD). 

As a former software engineer, she gained practical experience in the software lifecycle, from the initial formulation of a requirement, through to implementation of requirements, testing of software, and production of the required documentation. Verena was also focused on validation according to the GAMP 5 standard. 

After her role as a software engineer, Verena switched to Quality Management / Regulatory Affairs and worked on projects for the continuous improvement of QMS processes, in particular the software development processes according to IEC 62304, and the risk management processes according to ISO 14971. 

As an internal auditor, she conducted audits for the MDD and MDR, the 9001 and 13485 standards as well as MDSAP audits. She participated in various external audits related to medical devices and information security. 

Her role as quality manager also included the regular implementation of post-market surveillance activities and the preparation of related documentation and the processing of CAPAs. 

In her current position as a medical device consultant, she plays an active part in cybersecurity activities, including threat modelling, software composition analysis, and cybersecurity testing. While her background includes significant experience in Software as a Medical Device (SaMD), her recent focus has shifted toward embedded software. She also regularly supports clients in addressing usability challenges, a key factor in the development of safe and effective medical devices. 

Lorit Consultancy is an international company specialising in consulting, support, and training in the areas of functional safety and regulatory compliance. With many years of expertise in navigating the complexities of international safety standards, we help customers around the world successfully develop innovative and safe products.