Podcast: How should manufacturers update their QMS to meet the requirements of the European MDR?

Stephanie Goebel & Ortzi Olasolo from Beyond Conception talk to the JMDR about how to make a Quality Management System ready for the EU MDR. Watch/listen to our FREE PODCAST.

Stephanie Goebel is Senior Consultant at Beyond Conception GmbH. She is a medical engineer with 15 years of experience in medical devices and combination products and is an expert in drug/device combinations. She also worked as an auditor, technical documentation reviewer (MDD and ISO 13485) as well as product specialist on Article 117 (MDR) for a Notified Body and was a member of the Team NB (European Association of Notified Bodies) working group on Article 117 (MDR). Stephanie leads clients in their transition to the MDR through regulatory analysis, readiness audits/checks, and personalised training.

Ortzi Olasolo is Consultant at Beyond Conception GmbH. Ortzi holds a BSc in Biomedical Engineering from the Technical University of Madrid (Spain) and an MSc in Biomedical Technologies from the University of Navarra (Spain). He has dedicated most of his career to the design and development of medical devices, where he possesses a strong technical and regulatory background.

Beyond Conception is a Switzerland-based consulting company working in the life sciences industry, with a focus on medical devices, packaging technologies and information security.