TY - GEN A1 - Singh, Max Diamond T1 - MDR implementation status & lessons learned BT - MDR-Audtis – Best Practive & Learning, Tuttlingen, 10.02.2021 Y1 - 2021 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 - 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 - 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 - 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 - 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 - Technical Aspects for Navigated Sinus Surgery T2 - 4th Workshop on Endoscopic Surgery of the Maxillary Sinus and Navigation, Tübingen University Hospital, 2009 Y1 - 2009 ER - TY - GEN A1 - Singh, Max Diamond T1 - Overview of the Medical Device Regulation (MDR) BT - MDR-Roadshow TÜV SÜD MHS, San Diego & Minneapolis, 2018 Y1 - 2018 ER - TY - JOUR A1 - Singh, Max Diamond A1 - Terzidis, O. T1 - Introducing Innovation Phase Transition JF - International Journal of Innovation Science N2 - Innovation diffusion points toward how innovations spread into the market after launch. This paper investigates diffusion dynamics at market entry time and proposes a new evolution pattern at the intersection between inventions and innovations. With this in mind, we initially prove that patent filings correlate with new product introductions in the U.S. spine market. Then we test our new theory supposing that certain patent filing threshold numbers accelerate strong economic returns in terms of innovations. We find that firms hitting certain patent filing thresholds significantly increase their product launches in the mentioned market. Moreover, the results seem to indicate that economic returns of inventions may be measured substantially. Thus, this paper suggests a new research area by utilizing our proposed concept about an Innovation Outcome Trigger Value (IOTV). Furthermore, the implications may also be interesting for practitioners, since we empirically prove that inventive activities turn out to be worthwhile, indeed. Y1 - 2015 U6 - https://doi.org/10.1108/IJIS-07-04-2015-B003 SN - 1757-2223 VL - 7 IS - 4 SP - 249 EP - 262 PB - Emerald ER -