Inette Nieveen

Inette Nieveen

Borderline Devices Expert

Principal Consultant

Inette is an expert of Borderline Devices and is part of Qserve's Regulatory Affairs team. Her main areas of expertise are borderline products (devices for urinary tract and vaginal infections, obesity, bowel syndromes, allergy and dermatological indications).

She combines strong experience in quality management and regulatory affairs in food and medical devices, and B-to-C marketing with a pragmatic, pro-active and result-driven approach. She has dealt with the setup of Quality Management Systems and the certification and global registration of nonactive devices.

Prior to Qserve, Inette held several management positions in the health and medical device industry. Last 7 years she was responsible for Design and R&D, Quality Management and Regulatory Affairs at PK (Peters Krizman), an international medical device company. For PK Inette set up the ISO13485 quality system, managed the Notified Body assessments, compiled technical dossiers and clinical evaluations and was responsible for registrations and submissions of the medical device portfolio.
 
Inette has a degree in Food Technology (MSc.) and a track record of more than 20 years working experience in B-to-C marketing and sales in the health industry and in buying & merchandising in food- and drug retail.

Learn more about our services within Regulatory Affairs

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