TY - GEN A1 - Singh, Max Diamond T1 - Zusätzliche Anforderungen an Produktdaten und technische Dokumentation durch die MDR T2 - Medizintechnik Kongress 2018: Effizienz in der Medizinprodukteentwicklung vor dem Hintergrund von MDR und IVDR ; Frankfurt am Main, 08.11.2018, [Veranstalter: Velten Consulting & ILC Consulting] Y1 - 2018 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 - Conformity Assessment Procedure MDR BT - [Vortrag gehalten am 24.02.2020] T2 - MDR Training: Person Responsible for Regulatory Compliance Course, 24.-25.02.2020, Tel Aviv, Obelis Academy Y1 - 2020 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 - Notified body feedback: PSUR Forms. Post Market Surveillance & Vigilance BT - [Vortrag gehalten am 24.06.2020] T2 - MedTech Summit 2020: EU MDR & IVDR: the end is in sight, Dublin/virtual, 20.-26.06.2020 Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - MDR - Die neuen rechtlichen Bedingungen für Händler und Hersteller: aus der Sicht einer benannten Stelle T2 - MEGRA Jahrestagung. - Wien, 18.05.2020 [Veranstalter: Mitteleuropäische Gesellschaft für Regulatory Affairs] Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Innovation challenges for orthopedic device manufacturers under the new EU MDR BT - a notified body perspective T2 - ORS (Orthopaedic Research Society) Annual Meeting. - Phoenix, Arizona, 08. - 11.02.2020 Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - KARL STORZ Navigation Panel Unit - Navigation for ENT surgery T2 - FESS 2010 : International Workshop on FESS ; Lectures & Live Surgery. - Royal Pearl Hospital, Tiruchirappalli (Indien), 10.-11.04.2010 Y1 - 2010 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 - GEN A1 - Singh, Max Diamond T1 - Market Access for Devices under MDD and MDR: Obligations for Manufacturers T2 - OSMA - Orthopedic Surgical Manufacturers Association, Winter Educational Program - virtual Y1 - 2021 ER - TY - GEN A1 - Singh, Max Diamond T1 - Innovationsmanagement BT - Sitzung des Ulmer Arbeitskreises Innovationsmanagement, Ulm, 03.11.2011 Y1 - 2011 ER - TY - GEN A1 - Singh, Max Diamond T1 - General Overview of the Medical Device Regulation T2 - MDR-Roadshow - TÜV SÜD MHS, India Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Stakeholder view on Post Market Surveillance under the EU MDR: Timelines, Compliance and Requirements ; Post Market Surveillance & Vigilance BT - [Vortrag gehalten am: 23.6.2020] T2 - MedTech summit 2020: EU MDR & IVDR: the end ist in sight, 22.-26.06.2020, Dublin/virtual Y1 - 2020 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 - Technical Documentation MDR / IVDR, including the Declaration of Conformity BT - [Vortrag gehalten am 24.02.2020] T2 - MDR Training: Person Responsible for Regulatory Compliance, 24.-25.02.2020, Tel Aviv, Obelis Academy Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Notified Body Viewpoint : Preparing for MDR/IVDR T2 - MDR/IVDR - Status Report from Stakeholders. Where are we now in November 2018? - Bern, 22.11.2018 - [Veranstalter: RAPS : Regulatory Affairs Professionals Society] Y1 - 2018 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 - Singh, Max Diamond T1 - Herausforderungen der Medizinprodukteindustrie bei der Internationalisierung T2 - Studienwoche an der HNU (Hochschule Neu-Ulm) 2020 Y1 - 2020 ER -