connect.raps.orgHome - RAPS Regulatory Exchange

');//]] Skip to main content (Press Enter). Sign in Skip auxiliary navigation (Press Enter). Contact Us Code of Conduct RAPS.org Home Quick Start Guide Skip main navigation (Press Enter). Toggle navigation Content types Announcements Blogs Communities Discussions Events Glossary Site Content Libraries Date range on this day between these dates Posted by Home Communities All Communities My Communities Regional Communities Chapters Events Upcoming Events Resources Resource Library Member Knowledge Center Acronyms and Definitions Guide RAPS Career Community Participate Post a Message Join a Community How to Have Success on RegEx Volunteer Volunteer with RAPS My Volunteer Profile Opportunities Home Previous Next Latest Discussions Medical Device Registration in Iraq By: Olivia Mullen , 3 minutes ago Posted in: Regulatory Open Forum Good morning from Birmingham, AL! We recently had a customer in Iraq claim that according to "new regulations" that they have to register our company, I'm assuming, with the Ministry of Health in Iraq. I have done some googling and I cannot find much, if any, information on anything saying that by March of 2021 we have to be registered. Now I should ... RE: Biocompatibility for 510(k) - Is USP Class VI ... By: Ted Heise , an hour ago Posted in: Regulatory Open Forum Dear Iida-san: The USP Class VI status would be helpful, but not sufficient. The reason is that the processing of the materials as they are used to manufacture the finished device also needs to be accounted for. This would include any processing aids (e.g., lubrication or cleaning) or potential residuals (e.g., from ethylene oxide sterilization). ... EU MDD Class I: Is there a Transition Period for up-classified ... By: Yael Himmel-Shlomo , 5 hours ago Posted in: Regulatory Open Forum Hello Everyone, I'm supporting a few Medical Software ('decision support') companies aiming to enter the EU market during the upcoming year. Specifically, I'm referring to Class I devices (currently not requiring NB), which will be up-classified to IIa under the MDR (under classification Rule 11) and require NB approval. How long can such devices ... RE: UK MDR 2019 | UKCA Conformity Assessment By: Martin De Bruin , 5 hours ago Posted in: Regulatory Open Forum The question from Antonio was regarding the role of importer in UK. The newest update of the MHRA guidance does briefly mention this. It states the following: ' In cases where the Great Britain importer is not the UK Responsible Person, the importer will be required to inform the relevant UK Responsible Person of their intention to import a device. ... RE: What have you seen for State of the Art Standards ... By: Shirley Kadouri , 6 hours ago Posted in: Regulatory Open Forum Hi, Same approach, ie most recent revision of standards is considered state of the art, is taken by other NBs too (eg TUV SÜD, DEKRA, BSI). GMED is traditionally a very conservative approach and likely prefer compliance to the MDD/AIMDD harmonized standards on the OJ till MDR one is published (which will not happen before early 2021, at best). ------------------------------ ... More Volunteer Appreciation 2020 Download Album × Replace with Existing Album Select an existing album from the list. Select Album Choose... Save Cancel As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts. A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here . Recent Shared Files Know Regulatory? Our firm does! Attachments By: Sarayu Venkataraman 19 hours ago Posted in: RAPS Career Community RE: 2020.10.13. MDR Annex II. vs. DHF/DMR By: Evangelos Tavandzis 13 days ago Posted in: Regulatory Open Forum [Free Webinar] Hidden Traps That Will Derail Your CER: ... By: Laurie Mitchell 14 days ago Posted in: Regulatory Open Forum I'm seeking a new job opportunity By: Godwin Brown 19 days ago Posted in: RAPS Florida Chapter More Most Active Members Mayte Martinez 430 Points Richard Vincins 420 Points Alaa El Kazak 391 Points Anne LeBlanc 387 Points Skip Navigation Links Privacy Policy Copyright © 2020 RAPS. All rights reserved. Powered by Higher Logic...