TY - GEN A1 - Singh, Max Diamond T1 - European Union MDRs impact on device manufacturers: Reprocessing of surgical invasive devices, critical timeliness and technical documentation requirements under MDR BT - [Vortrag gehalten am 26.03.2019] T2 - The validation of sterile medical devices: sterilization, packaging, biocompatibility, toxicology and reprocessing, Amsterdam, 26.03. - 28.03.2019 [Veranstalter: Nelson Labs ; Sterigenics] Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Challenges to innovate in the medical device industry under the light of the new EU MDR : a notified body perspective BT - Keynote Presentation. - Amsterdam, 21.-22.11.2019 // [Veranstalter: Samtek Group] T2 - Intelligent medical devices - the next disruptor in healthcare ; challenges and oppoertunieties: technical, clinical, regulatory and health economics/market access Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - EU Medical Device Regulation: Top Challenges of Orthopedic Manufacturers T2 - OMTEC 2019 : 15th Annual Orthopedic Manufacturing & Technology Exposition and Conference, Chicago, 11.6.2019 Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Managing Innovation from the Notified Body Perspective - Understanding the 3 C’s of EU Regulations to Ensure Product Compliance: Changes, Challenges and Contributions T2 - 3rd annual european medical device and diagnostic product development and management meeting, 12-13 February 2019, Brussels Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Quality in Medical Device Innovation for Start-ups, SME, and large enterprises through the new Medical Device Regulation T2 - 3rd European QA Conference, Dublin, 06. - 08.11.2019 Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Reclassification of Orthopedic Devices per the Medical Device Regulation T2 - OSMA Winter Educational Program, St. Petersburg/USA, 2019. - [Veranstalter: Orthopedic Surgical Manufacturers Association (OSMA)] Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Strategies to Navigate to the EU MDR and Clinical Requirements T2 - Regulatory Affairs Professionals Society (RAPS): Session 1 - Tampa, Florida 2019 Y1 - 2019 ER - TY - GEN A1 - Aurbach, Maximilian A1 - Süß, Franz A1 - Dendorfer, Sebastian T1 - The impact of the hill type muscle model on the glenohumeral joint reaction force T2 - 16th International Symposium on Computer Methods in Biomechanics and Biomedical Engineering (CMBBE) 2019, New York City, USA Y1 - 2019 ER - TY - GEN A1 - Käsbauer, Johannes A1 - Schmailzl, Anton A1 - Loose, Tobias A1 - Hierl, Stefan T1 - Potentials of the EFG-Method for Modeling Quasi-Simultaneous Laser Transmission Welding Considering the Melt Flow T2 - Simulationsforum 2019 - Schweißen und Wärmebehandlung, Weimar Y1 - 2019 ER - TY - GEN A1 - Wagner, Thomas A1 - Krenkel, Lars A1 - Dönitz, Christian A1 - Brawanski, Alexander T1 - Influence of CFD Strategy on WSS and OSI Determination for Intracranial Aneurysm Rupture Assessment T2 - 25th Congress of the European Society of Biomechanics, July 7-10, 2019, Vienna, Austria Y1 - 2019 ER -