Anna Pietersma

Clinical Evaluation expert

Anna Pietersma, PhD
Principal Consultant 

Prior to Qserve, Anna 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 and combination medical devices.

Anna holds more than 20 years of experience in Medical Device- and Pharmaceutical industries, specifically in Clinical Research and Product Development as well International Regulatory Affairs and Quality assurance. As a Principal QA/RA expert Anna has acquired experience in establishing Clinical Evaluation (CER) and Risk management processes that typically involve collaborative efforts of multiple disciplines located in different parts of an organization. In that perspective the following skills are considered critical: knowledge of regulatory requirements and expectations, project management, strategic thinking and change management, training and motivation skills.

Anna combines strong experience in clinical development, quality, and regulatory with a pragmatic, result driven approach at both operational and exec level. She has acted as a technical reviewer at a Notified Body with a large range of devices mostly in the non-active device area (disposables, implants, combination- and borderline products) in cardiovascular, intensive care, contraception, (pro) fertility and wound care fields.

Anna about working at Qserve:

"With over 15 years of experience in medical device development, both in the pre-market and post-market setting, I know what it takes to effectively plan and execute clinical trials. I have reviewed many clinical evaluations and clinical trial results as a former notified body reviewer. I consider my broad knowledge and experience in both regulatory and clinical fields essential in clinical strategy decision making. Plotting a successful clinical strategy together with a client is probably the most satisfying part of my job."

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