be-on-Quality GmbH

𝐁𝐞 𝐨𝐧 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 - 𝐲𝐨𝐮𝐫 𝐩𝐚𝐫𝐭𝐧𝐞𝐫 𝐟𝐨𝐫 𝐫𝐞𝐥𝐢𝐚𝐛𝐥𝐞 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐫𝐞𝐬𝐮𝐥𝐭𝐬 🔍✨ Check out our consulting services now! 💼✅ #MedicalDevice #InvitroDiagnostics #QualityManagement #ClinicalEvaluation #RegulatoryAffairs #IVDR #MDR #TechnicalDocumentation #Audit #Compliance #Consulting

🚀 𝐍𝐄𝐖: 𝐂𝐡𝐞𝐚𝐭𝐬𝐡𝐞𝐞𝐭 𝐟𝐨𝐫 𝐁𝐢𝐨𝐥𝐨𝐠𝐢𝐜𝐚𝐥 𝐄𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐨𝐧! 🧬✨ Are you looking for a compact overview for biological evaluation activities? 🔬 Our biological evaluation cheatsheet summarizes the most important information and step. #biologicalassessment #medicaldevices #ISO10993 #regulatorycompliance #cheatsheet

𝗪𝗵𝗮𝘁'𝘀 𝗡𝗲𝘄 𝗶𝗻 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 - 𝗗𝗲𝗰𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝟮𝟰   For a brief summary read our Regulatory Retrospective.  For details check out the latest guidelines, regulations and announcements Follow be-on-Quality GmbH on LinkedIn to stay updated on medical device guidelines and regulations being announced.    𝗘𝗨:   ● Q&A Obligation to inform in case of interruption or discontinuation of supply  https://lnkd.in/epPNZuWd ● MDCG 2024-16    Manufacturer Information Form  https://lnkd.in/dhCFJ95w ● MDCG 2024-16    Device Identification Table  https://lnkd.in/dqpHaanz  ● MDCG 2022-3 Rev. 1 Verification of manufactured class D IVDs by notified bodies  https://lnkd.in/eS93FYj4 ● MDCG 2019-13 Rev.1 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation  https://lnkd.in/dRJKUwxM    𝗨𝗦𝗔: ● Marketing Submission Recommen-dations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions   https://lnkd.in/e7rc9ZAX ● Global Unique Device Identification Database (GUDID)  https://lnkd.in/egcKRjAS ● Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices  DRAFT Guidance  https://lnkd.in/exPyTgWd    #RegulatoryAffairs #MDCG #MedicalDevice #InvitroDiagnostic #Guidelines #TechnicalDocumentation #QualityManagement #ClinicalEvaluation #PostMarketSurveillance #FDA #MDR

- Laughing Through AI Regulation Challenges For full episode check: https://lnkd.in/eYGgGp8f Monir El Azzouzi Stefan Bolleininger #easymedicaldevice #medicaldevice #regulatorycompliance

Short and fun summary about what we are facing as manufacturers support team.

✨ 𝐇𝐚𝐩𝐩𝐲 𝐍𝐞𝐰 𝐘𝐞𝐚𝐫! 🎉 A new chapter begins - and we look forward to writing it with you. The past year has shown us how much we can achieve together and we are grateful for all the moments we were able to share with you.   Let's approach 2025 with fresh energy, new ideas and a clear goal: To grow, learn and create great things together! 💡🚀   Thank you for being part of our community. We wish you a year full of success, health and joy! 💙   What's at the top of your list for 2025? We look forward to hearing your plans! ✨ #NewYear #2024 #ShapingTheFuture

🎉 𝐍𝐞𝐰 𝐘𝐞𝐚𝐫, 𝐍𝐞𝐰 𝐆𝐨𝐚𝐥𝐬- 𝐑𝐞𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐟𝐨𝐫 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐮𝐜𝐜𝐞𝐬𝐬 𝐢𝐧 𝟐𝟎𝟐𝟓 ! 🎯 As professionals in Regulatory Affairs for Medical Devices, the New Year is the perfect time to align our focus on strategies that ensure compliance, innovation, and product success. Here is our top list of new years resolutions: ✅ Start clinical evaluation as early as possible. Early initiation of the clinical evaluation process ensures planning of a profound an reliable clinical strategy. ✅ Perform chemical characterization as part of the biological evaluation process to ensure product safety and adherence to ISO 10993 requirements. ✅ Make a design freeze to stabilize development and finalize your documentation before regulatory submissions. ✅ Initiate changes via a controlled process (change requests) and ensure proper evaluation and documentation across the entire technical documentation (TD). 📢 How do you plan to elevate your regulatory and clinical processes in 2025? Let’s exchange ideas and inspire best practices! #RegulatoryAffairs #MedicalDevices #ClinicalEvaluation #QualityManagement #NewYearsResolutions #MedTech

2024 was a very amazing and very interesting year. Within all the days and nights, there was no stop, no pause no moment to stay. It was a fast-paced and also empowering year! New things came up, like the AI ACT or other regulations and other things got easier, like the notified bodies backlog. We are happy to share a lot of these moments with others, our achievements we made, projects and certifications we collaborated and clinets, for which the daylight got better during the support. Not to forget, all our appreciated talents and friends & family. We wish everyone a good start into 2025. Lot's of changes will come up, So stay tuned, stay happy! Stefan Bolleininger & the be-on-Quality Team

🎄✨ 𝑀𝑒𝑟𝑟𝑦 𝐶ℎ𝑟𝑖𝑠𝑡𝑚𝑎𝑠 𝑓𝑟𝑜𝑚 𝑏𝑒-𝑜𝑛-𝑄𝑢𝑎𝑙𝑖𝑡𝑦! ✨🎄 As the year comes to a close, we want to take a moment to thank all of you—our clients, partners, and followers—for being part of our journey this year. 2024 has been a year of growth, challenges, and exciting accomplishments, and we couldn’t have done it without your trust and support. Now, it’s time to relax, celebrate, and recharge for an even brighter 2025! From all of us at 𝑏𝑒-𝑜𝑛-𝑄𝑢𝑎𝑙𝑖𝑡𝑦, we wish you a holiday season filled with joy, love, and cherished moments with family and friends. May the new year bring you success, happiness, and quality in all aspects of life. ✨ 𝑇ℎ𝑎𝑛𝑘 𝑦𝑜𝑢 𝑓𝑜𝑟 𝑏𝑒𝑖𝑛𝑔 𝑝𝑎𝑟𝑡 𝑜𝑓 𝑜𝑢𝑟 𝑠𝑡𝑜𝑟𝑦! ✨ #MerryChristmas #AdventCalender #ThankYou #Gratitude #TeamSpirit

🎅🎶 𝑺𝒂𝒏𝒕𝒂’𝒔 𝑮𝒐𝒕 𝒕𝒉𝒆 𝑱𝒂𝒎𝒔 🎶🎅 Get ready to groove because this year, the 𝑏𝑒-𝑜𝑛-𝑄𝑢𝑎𝑙𝑖𝑡𝑦 team has taken the reins and curated the ultimate playlists for our X-Mas party! 🍽️ 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐉𝐚𝐦𝐬: 𝐂𝐡𝐫𝐢𝐬𝐭𝐦𝐚𝐬 𝐃𝐢𝐧𝐧𝐞𝐫 𝐇𝐢𝐭𝐬 – A smooth and festive mix to create the perfect backdrop for a cozy dinner and meaningful conversations. 🎉 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐉𝐚𝐦𝐬: 𝐂𝐡𝐫𝐢𝐬𝐭𝐦𝐚𝐬 𝐏𝐚𝐫𝐭𝐲 𝐇𝐢𝐭𝐬 – Packed with high-energy and modern beats to keep the dance floor alive all night long! These playlists are 100% employee-created 🔊 Hit play, enjoy the vibes, and let us know—what’s your favorite? Find our Spotify Playlists here: https://lnkd.in/d6R3Rm4W https://lnkd.in/dyYganDG   #QualityJams #XMasPartys #AdventCalender #TeamSpirit #FestiveFun #SantaJams