We can disclose that Lifecare Laboratory (Mainz, Germany) is considered ready for ISO 13485 audit. ISO 13485 is a Quality Management System specific to medical devices and covers the entire life cycle of a device, from design and development to production, installation, and servicing. Reference is made to Lifecare’s list of trigger events, as presented at the semi-annual report of August 20th, 2023, and later investor communication. The launch of an automated production line at Lifecare Laboratory by end of Q2 2024 is set as a major milestone, and on this basis the company aim to launch the first product in the veterinary market mid 2024. Lifecare has received confirmation that ISO 13485 audit at Lifecare Laboratory will be carried out in the course of November 2023. Provided a successful audit, the ISO 13485 Certificate can be expected issued early in 2024. This progress is in accordance with the current list of communicated trigger events. In April 2023, Lifecare Laboratory was ISO 9001 certified in line with the progress plan. Given a successful outcome of the upcoming audit, Lifecare Laboratory will be ISO 13485 Certified. Compliance with ISO 13485 is an important step on the route towards Lifecare’s ultimate goal; product CE mark necessary to enter the market with a medical device for humans. - Lifecare’s QMS team in Bergen and Mainz has worked structured over time to prepare us for this audit. It is vital for the integrity for the production of Sencell Continuous Glucose Monitor, and later commercialization of the product, that our Quality Management System are certified. We depend on the trust from the market and patient groups, that our processes meet international quality standards. It is therefore very motivating to be ready for the important round of certification in line with the timetable that we have communicated, says CEO Joacim Holter. #cgm #sensor #sensortechnology #diabetes ISO - International Organization for Standardization Prof. Dr. Dr. med. Andreas Pfützner Morten Foros Krohnstad Trine Teigland Hans Hekland Asle Steiestøl Wingsternes Aslak Fisketjønn Jo Oeding Amundstad Barbora Tencer Ahmad Fazli Julie Lundekvam Nicole Thomé Jordan Gardiner Tony James Mandar Mehta Christian Kuhl Dr Jeanette Hütges Lea Weingärtner Andreas Simon https://lnkd.in/dav8M4XR
Lifecare’s Post
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NPTEL23BT37S74230037020199589.pdf
archive.nptel.ac.in
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🎬 Here’s a behind-the-scenes look at the making of our Healthcare Experts talk video series at Syensqo! Covering essential topics such as Simulation & ADL, Chemical Resistance, Regulatory Support, and Sterilization, we aim to start meaningful conversations. Don’t miss the first video release next week! #Syensqo #HealthcareInnovation #BTS #WeAreExplorers
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As a global citizen, I love to work with different cultures and try to make them successful.
𝗞𝗲𝗲𝗽𝗶𝗻𝗴 𝗜𝘁 𝗦𝗮𝗳𝗲: 𝗦𝘁𝗿𝗲𝗮𝗺𝗹𝗶𝗻𝗲 𝗬𝗼𝘂𝗿 𝗣𝗵𝗮𝗿𝗺𝗮 𝗣𝗮𝗰𝗸𝗮𝗴𝗶𝗻𝗴 𝘄𝗶𝘁𝗵 𝗕𝗲𝗻𝗶𝘄𝗮 The world of medicine needs packaging that's super secure and clean to keep everyone safe. But all the rules and regulations can make it tricky to get things done quickly. 𝐓𝐡𝐚𝐭'𝐬 𝐰𝐡𝐞𝐫𝐞 𝐁𝐞𝐧𝐢𝐰𝐚 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲 𝐜𝐨𝐦𝐞𝐬 𝐢𝐧! We're experts in making things run smoothly (like a well-oiled machine!), which is perfect for keeping your medical product packaging on track. Here's how we can help: ⦿ 𝐅𝐚𝐬𝐭𝐞𝐫 𝐏𝐚𝐜𝐤𝐚𝐠𝐢𝐧𝐠, 𝐅𝐞𝐰𝐞𝐫 𝐃𝐞𝐥𝐚𝐲𝐬: We'll help you find ways to package your medicine quicker, without cutting corners on safety. ⦿ 𝐃𝐨𝐮𝐛𝐥𝐞-𝐂𝐡𝐞𝐜𝐤𝐢𝐧𝐠 𝐄𝐯𝐞𝐫𝐲𝐭𝐡𝐢𝐧𝐠: We'll set up fancy machines that inspect every package to make sure it's clean and perfect. ⦿ 𝐂𝐥𝐞𝐚𝐫 𝐈𝐧𝐬𝐭𝐫𝐮𝐜𝐭𝐢𝐨𝐧𝐬, 𝐅𝐞𝐰𝐞𝐫 𝐌𝐢𝐬𝐭𝐚𝐤𝐞𝐬: We'll create clear and simple steps for everyone who packages your medicine, so there's no room for confusion. 𝐁𝐲 𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐁𝐞𝐧𝐢𝐰𝐚 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲, 𝐲𝐨𝐮 𝐠𝐞𝐭: ⦿ 𝐋𝐞𝐬𝐬 𝐑𝐢𝐬𝐤 𝐨𝐟 𝐓𝐫𝐨𝐮𝐛𝐥𝐞: Fewer mistakes mean you're less likely to have problems with the rules. ✅ ⦿ 𝐅𝐚𝐬𝐭𝐞𝐫 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧: Getting things done quicker saves you time and money! ⏱️ ⦿ 𝐒𝐚𝐟𝐞𝐫 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐞 𝐟𝐨𝐫 𝐄𝐯𝐞𝐫𝐲𝐨𝐧𝐞: The most important part - patients get the clean, safe medicine they need! 𝐑𝐞𝐚𝐝𝐲 𝐭𝐨 𝐦𝐚𝐤𝐞 𝐲𝐨𝐮𝐫 𝐩𝐡𝐚𝐫𝐦𝐚 𝐩𝐚𝐜𝐤𝐚𝐠𝐢𝐧𝐠 𝐚 𝐛𝐫𝐞𝐞𝐳𝐞? 𝐅𝐨𝐫 𝐦𝐨𝐫𝐞 𝐢𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧, 𝐩𝐥𝐞𝐚𝐬𝐞 𝐯𝗶𝘀𝗶𝘁 𝗼𝘂𝗿 𝘄𝗲𝗯𝘀𝗶𝘁𝗲: 𝒘𝒘𝒘.𝒃𝒆𝒏𝒊𝒘𝒂𝒕𝒆𝒄𝒉𝒏𝒐𝒍𝒐𝒈𝒚.𝒄𝒐𝒎 𝗘𝗺𝗮𝗶𝗹 𝘂𝘀: For further information or to discuss your specific needs, please email us at 𝒔𝒖𝒑𝒑𝒐𝒓𝒕@𝒃𝒆𝒏𝒊𝒘𝒂𝒕𝒆𝒄𝒉𝒏𝒐𝒍𝒐𝒈𝒚.𝒄𝒐𝒎. 𝐋𝐞𝐭'𝐬 𝐜𝐡𝐚𝐭 𝐚𝐛𝐨𝐮𝐭 𝐡𝐨𝐰 𝐰𝐞 𝐜𝐚𝐧 𝐡𝐞𝐥𝐩 𝐲𝐨𝐮 𝐩𝐚𝐜𝐤𝐚𝐠𝐞 𝐲𝐨𝐮𝐫 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐞 𝐟𝐚𝐬𝐭𝐞𝐫 𝐚𝐧𝐝 𝐤𝐞𝐞𝐩 𝐞𝐯𝐞𝐫𝐲𝐨𝐧𝐞 𝐬𝐚𝐟𝐞. #PharmaPackaging #MedicalProducts #SafetyFirst #EfficiencyExperts #BeniwaTechnology
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𝗞𝗲𝗲𝗽𝗶𝗻𝗴 𝗜𝘁 𝗦𝗮𝗳𝗲: 𝗦𝘁𝗿𝗲𝗮𝗺𝗹𝗶𝗻𝗲 𝗬𝗼𝘂𝗿 𝗣𝗵𝗮𝗿𝗺𝗮 𝗣𝗮𝗰𝗸𝗮𝗴𝗶𝗻𝗴 𝘄𝗶𝘁𝗵 𝗕𝗲𝗻𝗶𝘄𝗮 The world of medicine needs packaging that's super secure and clean to keep everyone safe. But all the rules and regulations can make it tricky to get things done quickly. 𝐓𝐡𝐚𝐭'𝐬 𝐰𝐡𝐞𝐫𝐞 𝐁𝐞𝐧𝐢𝐰𝐚 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲 𝐜𝐨𝐦𝐞𝐬 𝐢𝐧! We're experts in making things run smoothly (like a well-oiled machine!), which is perfect for keeping your medical product packaging on track. Here's how we can help: ⦿ 𝐅𝐚𝐬𝐭𝐞𝐫 𝐏𝐚𝐜𝐤𝐚𝐠𝐢𝐧𝐠, 𝐅𝐞𝐰𝐞𝐫 𝐃𝐞𝐥𝐚𝐲𝐬: We'll help you find ways to package your medicine quicker, without cutting corners on safety. ⦿ 𝐃𝐨𝐮𝐛𝐥𝐞-𝐂𝐡𝐞𝐜𝐤𝐢𝐧𝐠 𝐄𝐯𝐞𝐫𝐲𝐭𝐡𝐢𝐧𝐠: We'll set up fancy machines that inspect every package to make sure it's clean and perfect. ⦿ 𝐂𝐥𝐞𝐚𝐫 𝐈𝐧𝐬𝐭𝐫𝐮𝐜𝐭𝐢𝐨𝐧𝐬, 𝐅𝐞𝐰𝐞𝐫 𝐌𝐢𝐬𝐭𝐚𝐤𝐞𝐬: We'll create clear and simple steps for everyone who packages your medicine, so there's no room for confusion. 𝐁𝐲 𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐁𝐞𝐧𝐢𝐰𝐚 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲, 𝐲𝐨𝐮 𝐠𝐞𝐭: ⦿ 𝐋𝐞𝐬𝐬 𝐑𝐢𝐬𝐤 𝐨𝐟 𝐓𝐫𝐨𝐮𝐛𝐥𝐞: Fewer mistakes mean you're less likely to have problems with the rules. ⦿ 𝐅𝐚𝐬𝐭𝐞𝐫 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧: Getting things done quicker saves you time and money! ⦿ 𝐒𝐚𝐟𝐞𝐫 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐞 𝐟𝐨𝐫 𝐄𝐯𝐞𝐫𝐲𝐨𝐧𝐞: The most important part - patients get the clean, safe medicine they need! 𝐑𝐞𝐚𝐝𝐲 𝐭𝐨 𝐦𝐚𝐤𝐞 𝐲𝐨𝐮𝐫 𝐩𝐡𝐚𝐫𝐦𝐚 𝐩𝐚𝐜𝐤𝐚𝐠𝐢𝐧𝐠 𝐚 𝐛𝐫𝐞𝐞𝐳𝐞? 𝐅𝐨𝐫 𝐦𝐨𝐫𝐞 𝐢𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧, 𝐩𝐥𝐞𝐚𝐬𝐞 𝐯𝗶𝘀𝗶𝘁 𝗼𝘂𝗿 𝘄𝗲𝗯𝘀𝗶𝘁𝗲: 𝒘𝒘𝒘.𝒃𝒆𝒏𝒊𝒘𝒂𝒕𝒆𝒄𝒉𝒏𝒐𝒍𝒐𝒈𝒚.𝒄𝒐𝒎 𝗘𝗺𝗮𝗶𝗹 𝘂𝘀: For further information or to discuss your specific needs, please email us at 𝒔𝒖𝒑𝒑𝒐𝒓𝒕@𝒃𝒆𝒏𝒊𝒘𝒂𝒕𝒆𝒄𝒉𝒏𝒐𝒍𝒐𝒈𝒚.𝒄𝒐𝒎. 𝐋𝐞𝐭'𝐬 𝐜𝐡𝐚𝐭 𝐚𝐛𝐨𝐮𝐭 𝐡𝐨𝐰 𝐰𝐞 𝐜𝐚𝐧 𝐡𝐞𝐥𝐩 𝐲𝐨𝐮 𝐩𝐚𝐜𝐤𝐚𝐠𝐞 𝐲𝐨𝐮𝐫 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐞 𝐟𝐚𝐬𝐭𝐞𝐫 𝐚𝐧𝐝 𝐤𝐞𝐞𝐩 𝐞𝐯𝐞𝐫𝐲𝐨𝐧𝐞 𝐬𝐚𝐟𝐞. #PharmaPackaging #MedicalProducts #SafetyFirst #EfficiencyExperts #BeniwaTechnology
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The lifecycle approach significantly influences process validation compared to traditional one-time validation. This is also true for cleaning processes where a science- and risk-based approach is required. Understanding cleaning parameters is crucial for safe results. Adapting cleaning methods throughout the product lifecycle is essential, along with economic and environmental considerations. Optimal cleaning procedures offer flexibility and control, presenting potential cost savings and ensuring valid results throughout the product lifecycle. 🔄💡🌱 Visit our booth C1 at PharmaTechnica in Wiesbaden today and tomorrow to chat with our experts Duško Filipović and Dr. Lorenz Egli about your challenges. We look forward to your visit! 🤝 #ValidatedCleaning #PharmaTechnica #LifecycleApproach #SmartCleaningConcepts #ValueConservation
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He/Him. Delivering innovative SaaS solutions for clinical trials. Interested in those that are reducing human suffering and solving humanity's problems.
Do you want to see how biopharmas seamlessly manage clinical issue management and eliminate reconciliation of deviations? Register now for the April 30 live demonstration and Q&A to learn more about the Quality-Clinical Operations Connection. https://bit.ly/4cWk7Jf #clinicaloperations #ctms #qms #veeva
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Senior Product Manager | Director | B2B | B2C | SaaS | Cloud | Strategic planning | AI | Technology |
Free medical advice. Connect or Follow me for more nuggets of wisdom. #interesting #positivevibe #goodnews #postoftheday #wfh #vita #serbia #productmanagement #product #dailynews #dailypost #parenting #tech #statistics #world.
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Co-Founder / Director of T-A labs UK & Ireland
10moCongratulations to all involved in achieving this milestone….. 👏