Training sessions are organized in-house or on location:

ISO 10993: Biocompatibility of medical devices
ISO 13485: Quality systems for medical device manufacturers
ISO 14155 and other GCP-related aspects for Clinical trials
ISO 14971: Medical Device Risk Management
ISO 15189: Quality Management Systems for Clinical Laboratories
ISO 15224: Quality Management System for Health Care organisations
Clinical Trial Project Management: junior or senior level
Medical Device Directive (93/42/EEC) and Regulations (2016)
Advanced Therapy Medicinal Products (EC/1394/2007)
In vitro medical device Directive (98/79/EC) and Regulations (2016)

Please send your request for details and free quotes to



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ISO 14155:2011 Clinical Investigations of medical devices in human subjects

Clinical Project Management - CPM


LINC: Leipzig Interventional Course

Leipzig, 25 - 28 January 2012

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Unizo Startraad

Brussels, 16 January 2012

Cooperation with UNIZO related to start-ups

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Dutch Life Science & Health Conference

Utrecht, Jaarbeurs 13th December 2011

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