BaxMed Regulatory Ltd

Happy International Day of Women and Girls in Science! 🌍💫 Did you have a science obsession as a kid, battling gender stereotypes like a superhero? Let’s hear your stories! 💪🔬 #WomenInScience #GirlPower

It's Wednesday, which means it's time for our third expert session on PMS. Don't miss out on these valuable insights! What is Post Market Clinical Follow up? 🤷 🌟For a medical device legal manufacturer, PMCF is a key part of Post Market Surveillance activities and ultimately contributes to the body of evidence for claiming the device safety, performance and effectiveness. 🌟PMCF is an ongoing process for proactively collect and evaluate clinical data on a medical device which has been placed on the market. 🚨PMCF is a regulatory requirement of (EU) MDR 2017/745 and is detailed in Annex XIV Part B. When building the technical documentation for a medical device, an important consideration is evidencing compliance with the General Safety and Performance Requirements. What are we looking for when collecting and evaluating clinical data? ✅Gather additional real world clinical evidence data to support safety and performance claims ✅ Check if there are there any risks evident from the data which were not previously identified? ✅Trending of the data to identify any issues not previously detected ✅Data will contribute to the periodic safety update, PMS, risk management and clinical evaluation If you would like more information one of our team would be happy to help. #PMS #MDR #medicaldevice #RA #QA

How are you celebrating National Walking the Dog Day? 🐶🚶♂️ Meet our handsome, blue-eyed boy at BaxMed HQ—aptly named Blue! 💙 🐾We’re all about our four-legged friends and love any excuse to get outside for an adventure. Where are you and your pup exploring today? 🐾✨

We will be at the Biotech and Beers event in Edinburgh tonight! Looking forward to seeing many of you there!

📢The new UK PMS Regulation (PMS SI) will come into force on 16th June 2025 (https://lnkd.in/ezBVsq39). 🌟The new legislation is closely aligned with the EU (MDR/IVDR) PMS structure, UK have adopted the same PMS Plan, PMS Report and PSUR terminology. There are a few differences, for example; Definitions: 💎Preventive Action - the UK has a broader scope including actions not arising from a non-conformity. 💎Incident - captures more failures than EU scope. 💎Serious Incident - the UK definition is the same as the EU, however is expanded to include more potential scenarios thus capturing more types of serious incidents. 📃Reporting: 📝Information - there are specific requirements for the information that needs to be included in serious incident reports. 📝Type of Reports - Serious incidents resulted from expected & documented side effects require to be reported in UK, there is a exception in EU for these types of incidents. 📝How to Report - Submission via the MORE portal https://lnkd.in/ebhxy9HG 📝FSCA/FSN - Include the UKRP on FSCAs/FSNs, MHRA also require FSCAs that happened in other countries for the same device model to be reported. 📝Trending - MHRA require responses to requests from them within 3 working days. PMS Report/PSUR: ⏰Timings - PMSR to be produced within 3 years of placing on the market, then updated at least every 3 years, PSUR for class IIa devices within 2 years of placing on the market, then updated at least every 2 years, other devices and IVDs within the first year of placing on the market and and updated annually, 🥇Classification - based on what the device is regulated under (EU/UK) 💉Content - include estimates of numbers using the device in UK and outside also, characteristics of the population using the device, as well as description of any CAPA and rationale, conclusions of PMCF(if any) 😎June is fast approaching, therefore it is recommended that PMS/Reporting procedures are reviewed and updated to ensure they are ready to be compliant by then. BaxMed Regulatory Ltd are here to assist you to transition, get in touch to discuss how we can help.

As a startup, you may think of implementing an eQMS later on. What’s holding you back? We have a solution arriving in just 11 days! Stay tuned! 🚀 #innovation #startup #medicaldevice #regulatory #whatisthesolution

🎉 Happy Monday, LinkedIn! We are excited to share that we're launching something transformative for your revision control of technical files! 🚀 Stay tuned for updates! #Innovation #TechLaunch #Excited

This weeks candidate of the week is available immediately for interview! A welcome addition to an early start up looking to achieve commercialisation or and established business would benefit from this candidates experience. Experienced R&D leader with a strong background in medical device development, system integration, and regulatory compliance (FDA, IVDR, ISO 13485). Expert in product lifecycle management, risk assessment, and cybersecurity compliance, with a proven track record of delivering innovative, market-ready solutions. Fluent in English and Polish

Happy Valentines Day! or Galentines or even Palentines! Its a day to show appreciation for those we love ❤️ Sometimes even a professional relationship needs to be celebrated, so we are making the most of the day of love and letting you know what we love at BaxMed HQ! We love our team We love our clients We love our scientific community and We love nothing more than to see our clients success. #thankful #feelthelove #valentines #galentines #palentines

🚀 Say goodbye to document chaos! 📂 ✨ We have an AMAZING solution! 🤩 Curious about what we've got in store? Get ready to be blown away – only 15 days left until our new product launch! 🎉 Stay tuned to our socials for the BIG reveal! #Excitement #Innovation #StayTuned