@misc{Singh, author = {Singh, Max Diamond}, title = {European Union MDRs impact on device manufacturers: Reprocessing of surgical invasive devices, critical timeliness and technical documentation requirements under MDR}, series = {The validation of sterile medical devices: sterilization, packaging, biocompatibility, toxicology and reprocessing, Amsterdam, 26.03. - 28.03.2019 [Veranstalter: Nelson Labs ; Sterigenics]}, journal = {The validation of sterile medical devices: sterilization, packaging, biocompatibility, toxicology and reprocessing, Amsterdam, 26.03. - 28.03.2019 [Veranstalter: Nelson Labs ; Sterigenics]}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Challenges to innovate in the medical device industry under the light of the new EU MDR : a notified body perspective}, series = {Intelligent medical devices - the next disruptor in healthcare ; challenges and oppoertunieties: technical, clinical, regulatory and health economics/market access}, journal = {Intelligent medical devices - the next disruptor in healthcare ; challenges and oppoertunieties: technical, clinical, regulatory and health economics/market access}, 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 = {EU-MDR from a Notified Body Perspective - aktuelle Situation hinsichtlich der Anforderungen zum Lieferantenmanagement}, language = {de} } @misc{Singh, author = {Singh, Max Diamond}, title = {EU Medical Device Regulation: Top Challenges of Orthopedic Manufacturers}, series = {OMTEC 2019 : 15th Annual Orthopedic Manufacturing \& Technology Exposition and Conference, Chicago, 11.6.2019}, journal = {OMTEC 2019 : 15th Annual Orthopedic Manufacturing \& Technology Exposition and Conference, Chicago, 11.6.2019}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Conformity Assessment Procedure MDR}, series = {MDR Training: Person Responsible for Regulatory Compliance Course, 24.-25.02.2020, Tel Aviv, Obelis Academy}, journal = {MDR Training: Person Responsible for Regulatory Compliance Course, 24.-25.02.2020, Tel Aviv, Obelis Academy}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {Managing Innovation from the Notified Body Perspective - Understanding the 3 C's of EU Regulations to Ensure Product Compliance: Changes, Challenges and Contributions}, series = {3rd annual european medical device and diagnostic product development and management meeting, 12-13 February 2019, Brussels}, journal = {3rd annual european medical device and diagnostic product development and management meeting, 12-13 February 2019, Brussels}, 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 = {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 = {Innovation challenges for orthopedic device manufacturers under the new EU MDR}, series = {ORS (Orthopaedic Research Society) Annual Meeting. - Phoenix, Arizona, 08. - 11.02.2020}, journal = {ORS (Orthopaedic Research Society) Annual Meeting. - Phoenix, Arizona, 08. - 11.02.2020}, language = {en} } @misc{Singh, author = {Singh, Max Diamond}, title = {KARL STORZ Navigation Panel Unit - Navigation for ENT surgery}, series = {FESS 2010 : International Workshop on FESS ; Lectures \& Live Surgery. - Royal Pearl Hospital, Tiruchirappalli (Indien), 10.-11.04.2010}, journal = {FESS 2010 : International Workshop on FESS ; Lectures \& Live Surgery. - Royal Pearl Hospital, Tiruchirappalli (Indien), 10.-11.04.2010}, language = {en} } @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 = {Innovationsmanagement}, language = {de} } @misc{Singh, author = {Singh, Max Diamond}, title = {General Overview of the Medical Device Regulation}, series = {MDR-Roadshow - T{\"U}V S{\"U}D MHS, India}, journal = {MDR-Roadshow - T{\"U}V S{\"U}D MHS, India}, 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 = {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 = {Reclassification of Orthopedic Devices per the Medical Device Regulation}, series = {OSMA Winter Educational Program, St. Petersburg/USA, 2019. - [Veranstalter: Orthopedic Surgical Manufacturers Association (OSMA)]}, journal = {OSMA Winter Educational Program, St. Petersburg/USA, 2019. - [Veranstalter: Orthopedic Surgical Manufacturers Association (OSMA)]}, language = {en} }