PPT-New European Medical Device Regulations – major changes that will affect all devices

Rene van de Zande EMERGO President amp CEO 1 512 327 9997 rvzemergogroupcom March 31 2016 New European Medical Device Legislation Two Drafts MDR 1204015 and IVDR 1204215. devices. in. . Australia. Overview. Comparing medicines and medical devices. What is a medical device?. Statistics on patients requiring medical devices. How does a medical device get to market?. The benefit versus risk approach. Gary Quinn, CPPM. University of Texas. Southwestern Medical Center. What is Medical/Scientific Equipment?. Equipment used in a medical or scientific lab. Equipment used to treat patients. Human. Animal. 1.1 Terminology of Medicine and Medical Devices. 1.2 Generalized Medical Instrumentation System. Figure 1.1 Generalized instrumentation system. The sensor converts energy or information from the . Gary Quinn, CPPM. University of Texas Southwestern Medical Center. What is Medical/Scientific Equipment?. Equipment used in a medical or scientific lab. Equipment used to treat patients. Human. Animal. Office of Health & Information Technologies. Cary Ingram. CNTE Lead. Office of Health & . Information Technologies. Linda Astor. Acting Information Tech Lead. Office of Health & . Information Technologies. devices. in. . Australia. Overview. Comparing medicines and medical devices. What is a medical device?. Statistics on patients requiring medical devices. How does a medical device get to market?. The benefit versus risk approach. Shannon . Nees. , PGY-2. December 9, 2013. Outline. Medical device development and approval. Medical devices in pediatrics. History of pediatric device legislation. Current and future legislation. What is a medical device?. Frugal Biodesign : A systems approach for medical devices innovation Sudesh Sivarasu PhD Associate Professor – University of Cape Town, South Africa Conflict of Interest None South African Medical Device Industry Adverse event notification, investigation and regulatory reporting in the United States. . Tobey Clark, Director*, Burlington USA. Fourth WHO Global Forum on Medical Devices. 1. * WHO Collaborating Center for Health Technology Management. Medical devices session. Auckland . 19 March 2019. Therapeutic Products Bill: Devices Session. Agenda for today:. Purpose & design of the Bill . Scope & . Definitions. 1 - alone software including apps (including IVDMDs) v1.08 Application of this Guidance This guidance is applicable to standalone software and apps placed on the Great Britain market. Great Britain i Atsushi Tamura, Ph. D.PMDA, JAPANSeoul, KOREAJuly 4~5, 2011 2011 AHC Workshop on Medical Devices: “Implementation of GHTF Documents ” Pharmaceutical Affairs Law (PAL) Pharmaceutical Affairs Medical Device Coordination Group Document MDCG 2021 - 24 1 MDCG 2021 - 24 Guidance on classification of medical devices October 2021 This document has been endorsed by the Medical Device Coordinati Kristopher . Kusche. , M.Eng., CISSP, CPHIMS, FHIMSS, HCISPP. Vice President and CISO, Albany Medical Center. Disclaimer. The presenter has no real or apparent conflicts and affirms that no remuneration or other compensation is being received for this presentation. In no way does the mention of specific vendors or products imply any endorsement of that vendor or product..