@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} } @misc{Singh, author = {Singh, Max Diamond}, title = {Technical Aspects for Navigated Sinus Surgery}, series = {4th Workshop on Endoscopic Surgery of the Maxillary Sinus and Navigation, T{\"u}bingen University Hospital, 2009}, journal = {4th Workshop on Endoscopic Surgery of the Maxillary Sinus and Navigation, T{\"u}bingen University Hospital, 2009}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Overview of the Medical Device Regulation (MDR)}, language = {en} } @incollection{SinghCapanni, author = {Singh, Max Diamond and Capanni, Felix}, title = {Medizintechnik-Spin-offs aus der Hochschule - Ein Prozessbeispiel}, series = {Entrepreneurship im Gesundheitswesen II}, booktitle = {Entrepreneurship im Gesundheitswesen II}, editor = {Pfannstiel Mario A., and Da-Cruz, Patrick and Rasche, Christoph}, publisher = {Springer Gabler}, address = {Wiesbaden}, isbn = {978-3-658-14781-5}, abstract = {Die Aufmerksamkeit f{\"u}r Unternehmensgr{\"u}ndungen hat in den letzten Jahren extrem zugenommen. Grunds{\"a}tzlich muss ein Start-up in einem kompetitiven Umfeld erfolgreich sein, um bestehen zu k{\"o}nnen. Der Weg dorthin wird maßgeblich beeinflusst durch Planung und finanzielle Ressourcen, die die Gr{\"u}nder bereitstellen m{\"u}ssen. In der Medizinprodukteindustrie kommen zus{\"a}tzlich große H{\"u}rden hinzu, die u. a. einen kurzen Produktlebenszyklus, lange Projektlaufzeiten, aufwendige klinische Studien und aktuell neue gesetzliche Verordnungen betreffen. Dieser Beitrag konzentriert sich zun{\"a}chst auf m{\"o}gliche F{\"o}rdermittel und Beratung von Start-up-Projekten aus dem Hochschulbereich. Aus einer Analyse derzeit existierender Gr{\"u}nderwettbewerbe im Hinblick auf das Gesundheitswesen werden dem Leser entsprechende Adressen zum Einwerben von F{\"o}rdermitteln geliefert. Dar{\"u}ber hinaus wird ein Pilot-Prozess vorgestellt, wie eine Ausgr{\"u}ndungsberatung an der Hochschule Ulm im Studiengang Medizintechnik derzeit verl{\"a}uft. Dies kann m{\"o}glicherweise ein Ankn{\"u}pfungspunkt f{\"u}r eine zuk{\"u}nftige Institutionalisierung von Spin-off-Vorhaben aus dem Hochschulbereich sein.}, language = {de} }