Emergent Medical Associates的动态

Are you ready for the HFMA Annual Conference in Vegas next week? We sure are! ???? Stop by Booth #1101 for the best swag at the show – and some great conversation about the latest tools and techniques in managing regulatory change. Let us know if you’ll be there! ?? #hfma

A common issue for medical device manufacturers of high risk devices that require an #SSCP: the volume of the SSCP. Reading Article 32 of Regulation (EU) 2017/745 one might assume that the SSCP creation is something straightforward. After that, reading MDCG 2019-9 might feel like a blow in the face. On top of that the regulation and the guidance are obviously understood differently by many people working on the manufacturers' side as well as on the notified body side. This has led to SSCPs with many pages, failing to meet the objective of the SSCP: to be a summary. I look forward to discussing the topic in a "Solution Circle" at #RAPSEUROConvergence 2024 in Berlin. The format will give participants the opportunity to share their experiences as well. #medicaldevices #regulatoryaffairs RAPS Deutschland e.V. Regulatory Affairs Professionals Society (RAPS) RAPS Europe

?? Exciting news from ITA International! They have been awarded $399,998.22 by the Department of Commerce's National Institute of Standards and Technology (NIST). This funding will support their innovative project to develop a novel Fitted Filtration Efficiency (FFE) protocol for assessing the efficacy of masks and respirators based on true exposure. This protocol will help consumers and manufacturers understand the expected fit and filtration efficiency for various face sizes and shapes. #SBIR #STTR ?? The project, part of the Small Business Innovation Research Program Phase I, aims to address the critical challenge of leakage and poor fit in common face mask products. The achievements from this Phase I project will pave the way for Phase II, where ITA International will complete the development of the FFE protocol and position the testing service for commercialization. The award spans 24 months, starting on October 1, 2024, and ending on September 30, 2026. #Innovation #Research #Healthcare

The countdown has begun! Only 10 days left until Brazilian iGaming Summit / BiS SiGMA Americas 2024! ?? This will be our first time exhibiting at this event, and we have prepared a very special booth. ?? Visit our booth N90 This is the perfect place to connect with our team, explore strategic partnerships, learn more about the Brazilian regulatory landscape, and much more. #BiSSigmaAmericas2024 #Innovation #Technology #RegulatoryInsights #Brazil #Networking #Octus #iGamingLegal

??? Second part of my chat with Markus Herzberg CEO of Swissvax AG ??? This time we discuss about Identity of a car and how modifications could alter it, or not. ?? Leave your comments. We read and reply to all of you. ?? More talks from The Motor Chain coming soon!

Today in history... ...In 1777, "Stars and Stripes" was adopted by Congress as the official flag of the United States of America, that is why, we are celebrating Flag Day! ...In 1940, the Swastika was hoisted on the Eiffel Tower as the German army entered and occupied Paris… a year later, President Franklin Roosevelt ordered the freezing of all German and Italian assets in the US. Nothing to celebrate... ...In 1993, the Medical Device Directive (93/42/EEC) was adopted to harmonize the laws relating to medical devices within the European Union, defining the requirements for a manufacturer to place a medical device on the European market legally. Conforming products would have a CE mark applied. This Directive is now being replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective 26 May 2021. Are we celebrating? #FlagDay #MedicalDevices #CEMark #Paris #TodayInHistory

??Soei Takes Another Major Step: Second CEX Listing Confirmed! ?? ??Another milestone achieved! Stay tuned for the big reveal of our latest CEX partner. This listing will boost Soei's visibility and accessibility. ?? ? Don't forget to drop your guesses in the comments below ?? #SOEI #CEXListing #SOI $SOI

We are counting down the days to the EPI Summit 2025. After a successful sponsorship in 2024, we couldn't be more excited to be a part of this prestigious event once again as a sponsor. Traditional exits often leave significant value on the table. Our CEPA-certified Guides are experts in maximizing the potential value of your clients' exits. Learn more on our landing page and meet our team of experienced CEPA Guides. www.CEPAPartner.com See you at the EPI Summit 2025 in 298 days, 19 hours, 13 minutes, and 18 seconds! #CountingTheDays #CEPACertified #PinnacleBusinessGuides #Pinnacle #EPISummit2025 #CEPAGuides #ExitValueOptimization #ValueAcceleration

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