CE_Check

Two weeks passed since our team ✈️ to the US to attend the TINC accelerator program🤩. So far, except enjoying ☀️🌊⛱🏄‍♂️, they've had a 👩‍💼workshop with Julie Hamna, visited @Stanford 🕍, had a business meeting with @WishShopping, and more. #cecheck #startuplife #businessgrowth

Due to the delay in the designation of #NotifiedBodies under the new #MDRs, #EU national authorities have started discussing whether they should step in and assess the #conformity of some of #MedTech products themselves ❗️😲 👉bit.ly/2IcU57W 👀#Regulations #MDR #IVDR

Have you heard of the #BXMmethod? 🙄 It's one of the best tools you can use to perform safety risk management for medical devices. Learn more about it here 👉 buff.ly/2JZbRgg #softwaretools #riskmanagement #quantitativemethods #ISO14971 #medicaldevices

What are the steps of the #riskmanagementprocess? What tools can be used for the identification and evaluation of #hazards? 🤔…. Find the answers 👉 buff.ly/2VeCcZQ 👈 ... It's highly recommended for manufacturers of #medicaldevices❕❗️#riskmanagament #usefultools

Our fantastic and thirsty for knowledge team is attending the TINC accelerator program in Silicon Valley this May!😎🇺🇸 According to Tobias Rydell, founder & CEO of CE Check, it's gonna be "a month full of insights, challenges and building relationships". bit.ly/2V1RSnY

#BEIS and #HMRC recently hosted a webinar (April 11, 2019) highlighting importing and exporting preparations businesses should take in the event of a no-deal #Brexit. Read the summary here 👉buff.ly/2IyvP1P #import #export #trade

What does the 🇺🇸 - 🇬🇧 Mutual Recognition Agreement state? What are the key points #US manufacturers must consider before exporting products to the #UK and the #EU? The answers to these❓❓❓can be found here 👉 buff.ly/2KSYMaL #Brexit #electricalequipment #CEmarking #UKCA

Regardless of whether we stay with #CEMarking or the new #UKCA mark over the coming months, UK set builders still need to ensure their systems comply. Gary Wilde from @bpmapumps explained the situation in the latest issue of flow magazine. buff.ly/2IaBWbF

ETSI EN 300 220-2 is necessary for CE marking of Short Range Devices (SRD) operating in the frequency range 25MHz to 1000 MHz #cemarking #etsi #harmonised #europeastandard #radioequipment #radioequipmentdirective #RED #CEmark #shortrangedevice #datatransmission #allemclabs

Countries that sent the most alerts to the EU Safety Gate (aka Rapid Alert System) in 2018: 🇩🇪Germany (362 alerts) 🇫🇷France (249 alerts) 🇭🇺Hungary (172 alerts) More results for each country in these factsheets ➡️ec.europa.eu/consumers/cons… #ProductSafety

Do you have a #medicaldevice software that needs to be CE marked? If your answer is 'Yes', then take a look at this #guide 👉buff.ly/2Ur8Zzf 👈 to learn how to pass the #certification process in 10 steps.😉 #software #apps #cemarking #medtech #eHealth

What will happen if the UK government is not able to secure parliamentary approval for any plan by April 12, 2019? Read this very comprehensive post to find out => buff.ly/2VxU2YP #Brexit #news #outcomes #cemarking #medtech

Two new #guidancedocuments on the #transition from the previous #PPE Directive 89/686/EEC to the PPE Regulation have been approved and released in March. The complete set of guidance documents can be found here =>lnkd.in/dxv4b9e #regulations #cemarking

We're delighted to announce our partnership with Merxona Consulting AB, who runs the virtual incubator MC Incubator™, which provides digital business coaching to start-ups in the Life Science area.😊👉bit.ly/CECheck-MC #businessnews #announcements #new #partnership

German medical device manufacturer Fresnius Medical Care will pay $231M in penalties and disgorgement for violating the Foreign Corrupt Practices Act by paying bribes in 13 countries and for failing to keep accurate books and records. justice.gov/opa/pr/freseni…

Still certifying #IT or #AV equipment to IEC/UL 60950 or 60065? Learn more about the new standard, IEC/UL 62368-1, which has an effective date of Dec. 2020. Download our complimentary white paper: ow.ly/to9D30o8oZ9

5 crucial factors you must consider when performing medical device risk assessment! Check here: buff.ly/2CEQz3m #medicaldevices #factors #riskassessment #riskmanagement #cemarking

The #EuropeanCommission launches a new portal that should help ease the transition to the new #Regulations for all stakeholders in the medical devices and in-vitro medical devices ecosystem.#MDR #IVDR #CEmarking #medicaldevices 👉med-technews.com/news/european-…

Happy #news! 😊 We raised 2.3 MSEK to scale up our digital #CEmarking platform and focus on the e-health sector. Hip hip hooray! 🎉🎉computersweden.idg.se/2.2683/1.71628…

What does a disorderly #Brexit mean for product conformity assessments and marking? 🤔 Learn here: buff.ly/2HGB7Hg #conformity #productsafety #regulations #cemarking #conformityassessment #Compliance