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There is a very nice summary of the impact on medical device manufacturers of the Johner Institut (https://www.johner-institut.de/blog/?p=936146). Unfortunately this article is in German, only.

A summary of the event taking place May 11 and 12 in the Otto Bock Science Center in Berlin. Markus Fleckenstein‌   (view in My Videos)

Regulatory Considerations in the Design and Manufacturing of Implantable 3D-Printed Medical Devices

FDA How 3D CAD and Printing are Paving Way for Personalized Medicine

LinkedIn Article - Mastering Requirements and Validation for Medical Devices

LiveWorx - Proposed Agenda for Healthcare & Medical Device Industry

2017 Medical Devices Manufacturers Software Selection Guide | PTC

Medical Devices: Making The Right Choice – Achieve The Case For Quality Webcast Replay | PTC

PLM for Medical Device Manufacturers | PTC

Accelerating Medical Device Innovation While Mastering the FDA Case for Quality – The Vital Role of PLMWe live in an age where innovation is driven by Digital Transformation. Medical Device Companies are facing the unique challenge of remaining competitive in an environment where increasing regulatory complexity is coupled with the demand for lower cost medical innovations in a connected world.Intense analysis of device quality data and feedback, from regulatory and industry stakeholders led the FDA to establish the Case for Quality. The objective being the advancement of medical device quality and safety to achieve better patient outcomes. The Case for Quality elevates the focus of medical device stakeholders from baseline regulatory compliance to sustained, predictive practices. This will inevitably lead to changes in procedures for product design and development.How can Medical Device Companies master the FDA Case for Quality in a time when Digital Transformation of the industry lea