@phdthesis{Singh, author = {Singh, Max Diamond}, title = {Aspects of the Dynamics of Spine Surgery Technologies: Assessing the Reality of Innovation and Entrepreneurship in the U.S. Medical Device Industry}, publisher = {Karlsruhe Institute of Technology}, address = {Karlsruhe}, pages = {xix, 254 S.}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {MDR - Die neuen rechtlichen Bedingungen f{\"u}r H{\"a}ndler und Hersteller: aus der Sicht einer benannten Stelle}, series = {MEGRA Jahrestagung. - Wien, 18.05.2020 [Veranstalter: Mitteleurop{\"a}ische Gesellschaft f{\"u}r Regulatory Affairs]}, journal = {MEGRA Jahrestagung. - Wien, 18.05.2020 [Veranstalter: Mitteleurop{\"a}ische Gesellschaft f{\"u}r Regulatory Affairs]}, language = {de} } @misc{Singh, author = {Singh, Max Diamond}, title = {Medical Device Regulation}, series = {Forum MedTech Pharma: Start-ups in der Medizintechnik: Besonderheiten und Fallbeispiele, M{\"u}nchen, 17.7.2019}, journal = {Forum MedTech Pharma: Start-ups in der Medizintechnik: Besonderheiten und Fallbeispiele, M{\"u}nchen, 17.7.2019}, language = {de} } @misc{Singh, author = {Singh, Max Diamond}, title = {Market Access for Devices under MDD and MDR: Obligations for Manufacturers}, series = {OSMA - Orthopedic Surgical Manufacturers Association, Winter Educational Program - virtual}, journal = {OSMA - Orthopedic Surgical Manufacturers Association, Winter Educational Program - virtual}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Herausforderungen der Medizinprodukteindustrie bei der Internationalisierung}, series = {Studienwoche an der HNU (Hochschule Neu-Ulm) 2020}, journal = {Studienwoche an der HNU (Hochschule Neu-Ulm) 2020}, language = {de} } @article{SinghRussTerzidis, author = {Singh, Max Diamond and Russ, Jochen and Terzidis, Orestis}, title = {The Impact of the ObamaCare Excise Tax on Innovation and Entrepreneurship - Early Empirical Findings}, series = {International Journal of Innovation Science}, volume = {7}, journal = {International Journal of Innovation Science}, number = {2}, publisher = {Emerald}, doi = {10.1260/1757-2223.7.2.75}, pages = {75 -- 90}, abstract = {This study addresses aspects of governmental influence on innovation by analyzing the impact of the ObamaCare excise tax on the medical device industry. We initially give an overview of common approaches to measuring innovativeness and entrepreneurship, empirically assess whether existing metrics are suitable for investigating the innovation performance of the U.S. medical device industry, and define a new measure (firm innovation activity) for entrepreneurship. Then we perform a quantitative analysis to explore the impact of the tax. We analyze more than 60,000 product clearances from 1996 to 2013, using the FDA database. We find a significant relationship between product counts and revenues for one segment. Contrary to the present criticism of the excise tax, we find hardly any noteworthy response in either firm innovation activity or number of products launched in the year after the tax was introduced. The 2013 reduction of new product submissions is well within the limits of typical annual fluctuations observed in previous years. This provides a first indication that the excise tax act did not have a strong impact on innovative activities through the present.}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Zus{\"a}tzliche Anforderungen an Produktdaten und technische Dokumentation durch die MDR}, series = {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]}, journal = {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]}, language = {de} } @misc{Singh, author = {Singh, Max Diamond}, title = {MDR Implementation Status and Lessons Learned from the Past Months: A Notified Body Perspective}, series = {Cambridge Healthtech Institute's 2nd Annual Medical Device Clinical Trial Design and Operations: Trial Design and Technology to Optimize Medical Device Trials, Orlando, Florida + Virtual, 02.-03.03.2021}, journal = {Cambridge Healthtech Institute's 2nd Annual Medical Device Clinical Trial Design and Operations: Trial Design and Technology to Optimize Medical Device Trials, Orlando, Florida + Virtual, 02.-03.03.2021}, publisher = {Cambridge Innovation Institute}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {MDR implementation status \& lessons learned}, language = {en} } @article{Singh, author = {Singh, Max Diamond}, title = {Orthopedic Medical Devices Under The Scope of The EU MDR}, series = {MedTech Outlook}, journal = {MedTech Outlook}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Stakeholder view on Post Market Surveillance under the EU MDR: Timelines, Compliance and Requirements ; Post Market Surveillance \& Vigilance}, series = {MedTech summit 2020: EU MDR \& IVDR: the end ist in sight, 22.-26.06.2020, Dublin/virtual}, journal = {MedTech summit 2020: EU MDR \& IVDR: the end ist in sight, 22.-26.06.2020, Dublin/virtual}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Quality in Medical Device Innovation for Start-ups, SME, and large enterprises through the new Medical Device Regulation}, series = {3rd European QA Conference, Dublin, 06. - 08.11.2019}, journal = {3rd European QA Conference, Dublin, 06. - 08.11.2019}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Notified body feedback: PSUR Forms. Post Market Surveillance \& Vigilance}, series = {MedTech Summit 2020: EU MDR \& IVDR: the end is in sight, Dublin/virtual, 20.-26.06.2020}, journal = {MedTech Summit 2020: EU MDR \& IVDR: the end is in sight, Dublin/virtual, 20.-26.06.2020}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Technical Documentation MDR / IVDR, including the Declaration of Conformity}, series = {MDR Training: Person Responsible for Regulatory Compliance, 24.-25.02.2020, Tel Aviv, Obelis Academy}, journal = {MDR Training: Person Responsible for Regulatory Compliance, 24.-25.02.2020, Tel Aviv, Obelis Academy}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Notified Body Viewpoint : Preparing for MDR/IVDR}, series = {MDR/IVDR - Status Report from Stakeholders. Where are we now in November 2018? - Bern, 22.11.2018 - [Veranstalter: RAPS : Regulatory Affairs Professionals Society]}, journal = {MDR/IVDR - Status Report from Stakeholders. Where are we now in November 2018? - Bern, 22.11.2018 - [Veranstalter: RAPS : Regulatory Affairs Professionals Society]}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Strategies to Navigate to the EU MDR and Clinical Requirements}, series = {Regulatory Affairs Professionals Society (RAPS): Session 1 - Tampa, Florida 2019}, journal = {Regulatory Affairs Professionals Society (RAPS): Session 1 - Tampa, Florida 2019}, language = {en} }