Anna Pietersma is Principal Consultant Regulatory & Clinical Affairs with Qserve Consultancy, specializing in medical device clinical evaluation. Anna holds a PhD in cellular biochemistry (COEUR Cardiovascular Research Institute, Rotterdam, The Netherlands) and a post academic grade in medical ethics (Radboud University, Nijmegen, The Netherlands). Anna holds over 10 years of experience in Medical Device industries, and 10 years of experience in pharmaceutical development and clinical research.
Prior to her current position at Qserve, Anna has held a number of key management positions in the Medical devices industry. In her last position Anna was Project manager Medical Devices at DEKRA Notified Body for high risk medical devices. As a senior Clinical scientist and QA/RA expert at Medtronic and MSD, Anna has acquired experience in establishing Clinical Evaluation and Risk management processes that typically involve collaborative efforts of multiple disciplines located in different parts of an organization. The following skills are considered essential: knowledge of regulatory requirements and expectations, clinical project management, strategic thinking and training skills.