@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} } @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 = {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 = {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 = {Joint NB-Position Paper on Spinal Classification per the MDR}, 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} } @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 = {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 = {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} }