ZOLL Cardiac Management Solutions’ Post

ICYMI: EU medical providers have full access to COBRA-OS®. 🌍 With this groundbreaking aortic occlusion device being granted CE marking under the new EU Medical Device Regulations, COBRA-OS® has transformed how medical providers manage bleeding emergencies. Curious to learn more? Read the full article linked below. ✨ https://lnkd.in/ee6UQQHK #cobraos #medicalinnovation #cemarking #frontlinemedtech #patientcare #aorticocclusion #healthcarerevolution

Question asked from the industry related to the Great Britain market:  𝐅𝐨𝐫 𝐡𝐨𝐰 𝐥𝐨𝐧𝐠 𝐜𝐚𝐧 𝐈 𝐩𝐮𝐭 𝐦𝐲 𝐂𝐄 𝐦𝐚𝐫𝐤𝐞𝐝 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐨𝐧 𝐭𝐡𝐞 𝐆𝐁 𝐦𝐚𝐫𝐤𝐞𝐭? Great Britain is set to extend its acceptance of CE-marked medical devices for up to year 2030 to avoid Brexit-related disruption. The new plan gives the industry even more time to adapt. Below the infographic of the timelines for placement of CE marked medical devices on the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023: Source: https://lnkd.in/gp5iM5d6 #KiwaMedical #Kiwa #Medicaldevices #CEmarking

3️⃣3️⃣ Days #To50andBeyond🚀🚀🚀 I had another post for “33 Days To…”-I’m saving that one for another day. I say this all the time “Small Business is Hard” - It can be rewarding but it isn’t easy. This reshare is a big part of my days lately. Not the first paragraph, our customers are quite understanding. We make mistakes. The second paragraph is experienced daily. In just shy of 50 years in business we are fortunate to have customers who are so loyal they’ve been with us since almost the beginning. We are grateful. 🧐 It is assumed by some of our customers that all companies operate in the customized way in which we do. Flood?-we’ll get those mats changed! Need extra for a special event? No problem! Need to make temporary changes? We got you. We’ve had customers switch service over the years simply because someone was a few cents less. “But we have to save”. “I’m going to give this other company a chance”. “This is a business decision”. Our customers generally return, but typically after a lengthy contract and price increases they never saw coming. Hughes Customat, Inc. Is a b2b service provider. We aren’t a business catering to the retail consumer. We are a small family business. We aren’t raking in profits or traded on the NYSE. The cost of doing business has increased greatly over the past few years. Pricing increases we’ve instituted don’t come close to the increases we’ve absorbed. I know I’m not alone here. This post isn’t to say we are losing business to the big companies-not at all. I can count on one hand how many have left us for large competitors this year. A few of these were due to national contracts and not the choice of our local contacts. Thanks to all supporting small businesses. Companies like ours are truly the backbone of our economy. #shoplocal #supportsmallbusiness #stlouis #mats

Navigating the diverse medical device registration landscapes in different countries can be tricky, tedious and time consuming. It also impacts fees, timelines, and your certificate validity. 📝 That's why it is crucial to work with knowledgeable authorised representatives to ensure compliance and long-term market presence. Andaman Medical offers comprehensive medical device registration services, providing independence and flexibility in market access. With local offices across Southeast Asia, they handle standard, abridged, and special access routes, along with renewals, change notifications, and licence transfers. Learn more about what we do here: https://lnkd.in/eduBQzH8 #andamanmedical #medicaldeviceregistrationsoutheastasia #medicaldeviceregistration

𝐇𝐞𝐲 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐫𝐞𝐩𝐬! When you reset trays and run them around? 𝐓𝐡𝐚𝐭 𝐭𝐢𝐦𝐞 𝐜𝐨𝐦𝐞𝐬 𝐨𝐮𝐭 𝐨𝐟 𝐲𝐨𝐮𝐫 𝐜𝐨𝐦𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬. This isn't an opinion or an argument. 𝐈𝐭'𝐬 𝐚 𝐬𝐭𝐚𝐭𝐞𝐦𝐞𝐧𝐭 𝐨𝐟 𝐟𝐚𝐜𝐭. Plan accordingly. #medicaldevices

Episode 48 of "Medical Compliance With Clarissa" is now live at https://lnkd.in/e2HTufXd. In this episode, host Clarissa Benfield talks to Intertek's Shiva Mokhberi about global market access for medical devices, #CBScheme and more! Tune in now to watch. #medicaldevice #medicalcompliance

🚨 Attention to all in the Medical Devices Sector! 🚨 🔊 The call has been made: It's time for separate rules! 🔊 🔍 The Association of Indian Medical Device Industry (AiMeD) has spoken, advocating for distinct regulations tailored to our unique sector. With the landscape evolving rapidly, it's crucial to ensure that regulations keep pace to support innovation and patient care. 💡 Separate rules mean tailored solutions. Let's champion this cause together for a brighter future in medical device innovation and regulation. Stay tuned for updates on this vital initiative! #MedicalDevices #Regulation #AntalInternational 🌟

*NEW EPISODE ALERT* Episode 37 of "Medical Compliance With Clarissa" is now live at https://lnkd.in/dmznTiAy and it's another timely one. Host Clarissa Benfield talks to Curtis Riley, head of Intertek's Medical Notified Body, about the #MedicalDeviceRegulation, how things are progressing, and deadlines that are now upon us (May 2024). If you're a medical device manufacturer selling into the EU, this is an episode you don't want to miss. #medicaldevice #MDR #Regulatory

Ending the year with a thought provoking discussion with Shiva Mokhberi - talking all things #CBScheme and market access. We are proud to offer CB Scheme to Medical Device manufacturers around the globe. Always happy to answer any questions or connect you with my teams. #medicaldevice #medicalcompliance #regulatory #globalmarketaccess

You may access to the recent released China Medical Device Standards (2024) - translated version in the below link. It covers a total of 1,975 medical device standards that are currently in effect. China is expediting the process of aligning its medical device standards with international ones. By the end of 2023, a total of 66 international standards have been adopted and officially included into China's Medical Device Standards, and another 86 international standards for medical devices have been approved for the transformation into national standards or industry standards. The overall consistency rate of international standards for medical devices will be well over 90%. Quick tips: * The mandatory national standard starts with “GB”, and the recommended national standard starts with “GB/T”. The mandatory industry standard is “YY”, and the recommended industry standard starts with “YY/T”. * When and how to use: During registration application, applicant will need to ensure the info reflected in their Product Technical Requirement document, particularly product specification, performance indicators, testing methods and terminologies, conforms with the current mandatory standards. If not, additional explanation materials will be requested. #CMDE (Center for Medical Device Evaluation) #NMPA #Medical Device Standards