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 - 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-MDR from a Notified Body Perspective - aktuelle Situation hinsichtlich der Anforderungen zum Lieferantenmanagement BT - Tuttlingen, Technology Mountains / Medical Mountains, 2019 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 - Joint NB-Position Paper on Spinal Classification per the MDR Y1 - 2019 UR - https://www.team-nb.org/wp-content/uploads/2019/01/Joint-NB-Spinal-Classification-Decision-Tree_final.pdf ER - TY - GEN A1 - Singh, Max Diamond T1 - Medical Device Regulation BT - Kurzer Überblick zur Zulassung von Medizinprodukten T2 - Forum MedTech Pharma: Start-ups in der Medizintechnik: Besonderheiten und Fallbeispiele, München, 17.7.2019 Y1 - 2019 ER - TY - JOUR A1 - Singh, Max Diamond T1 - Orthopedic Medical Devices Under The Scope of The EU MDR JF - MedTech Outlook Y1 - 2019 UR - https://embedded-solutions.medicaltechoutlook.com/cxoinsight/orthopedic-medical-devices-under-the-scope-of-the-eu-mdr-nwid-921.html 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 - Strategies to Navigate to the EU MDR and Clinical Requirements T2 - Regulatory Affairs Professionals Society (RAPS): Session 1 - Tampa, Florida 2019 Y1 - 2019 ER -