Wolfgang Prettner

Quality Management Health Products Medical Product Registration REHA.Complete Quality Management [EN ISO 13485] Risk Management [DIN EN ISO 14971] Software life cycle processes [IEC 62304]

Person Responsible for Regulatory Compliance (MDR) Based on article 15 of the EU MDR 2017/745 1. The conformity of medical devices is checked in accordance with the QM system 2. The technical documentation is kept up to date 3. Market surveillance is performed in compliance with the EU regulations 4. The reporting obligations according to the EU regulations are met

The responsibilities are the one mentioned on Article 15 of the EU MDR 2017/745.  The conformity of medical devices is checked in accordance with the QM system (before delivery) (Article 10(9)).  The technical documentation is kept up to date (Article 10(4) and (6)).  Market surveillance is performed in compliance with the EU regulations (Article 10(10)).  The reporting obligations according to the EU regulations are met (Article 10(13)).

Aufbau und Zertifizierung von Qualitätsmanagementsystemen Medizinprodukte MDR, ISO 13485, ISO 14971, IEC 62304, IEC 82304-1, IEC 62366,... Spezialist für Standalone Software Medizinprodukte

Delivery Management REHA.Complete

Managing the product development team in Austria and Russia Quality Management REHA.Complete

Identifikation und Generierung von neuen Wachstumsfeldern für die T-Systems Austria im Bereich des österreichischen und internationalen Gesundheitswesens. Aktueller Fokus liegt auf Kur-, Pflege-, und REHA-Einrichtungen

Responsible for Product Development in the field of Health Care: Leading the Software Development Teams, Product Management Team, Quality Management / QA Team

Head of Product Development, Quality Management, Product Management and ICT CGM CH is the Swiss leading ICT solution provider in the field of health care

Verantwortlich für Unternehmensentwicklung / Business Development in der CompuGroup CEE (Central und Eastern Europe) Die CompuGroup ist eines der führenden eHealth-Unternehmen weltweit

Softwareentwicklung Systema Human Information Systems Produktmanager und Abteilungsleiter - Softwareentwicklung Qualitätsmanagement Nationale und Internationale Entwicklungs-, Implementierungs- und Outsourcingprojekte

Gründung der Firma BIT Factory Software GmbH Produktentwicklung und Qualitätsmanagement 1999 Verkauf der Anteile an die Miteigentümer

General Management Entrepreneurship Unternehmensstrategie