be-on-Quality GmbH

🎉 𝐁𝐞𝐜𝐨𝐦𝐞 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐭𝐞𝐚𝐦! 🚀 Are you looking for a new challenge and want to work in a dedicated team? We have an exciting position available and are looking for a Consultant Clinical Affairs (m/f/x)! Send us your application to [email protected] 📩 #JobOpportunity #Career #NewTeamMember #JobOpportunity #YourNewJob #JoinourTeam #beonQuality

𝐂𝐲𝐛𝐞𝐫𝐬𝐞𝐜𝐮𝐫𝐢𝐭𝐲 𝐉𝐮𝐧𝐠𝐥𝐞 -𝐓𝐞𝐫𝐦𝐬 𝐔𝐧𝐥𝐨𝐜𝐤𝐞𝐝 Are you totally overwhelmed by all the standards, guidelines and white papers on cybersecurity? You can't see the wood for the trees? Start getting the big picture with our “Cybersecurity Terms Unlocked”. We summarized the most important terms plus explanations which occur frequently in the context of cybersecurity. #RegulatoryAffairs #MedicalDevices #InVitroDiagnosticDevices #Cybersecurity

Heute erhielten wir einen Überblick über die Rahmenbedingungen der Transformation von der 🚗Automobilzulieferindustrie in die 🏥Medizintechnik, 💡praktische Tipps und einen Ausblick in 📈zukünftige Entwicklungen der Branche. Mit diesen Insights können wir klar sagen: Die Diversifikation in neue Branchen wie die Medizintechnik stellt einen vielversprechenden Ansatz für Automotive-Unternehmen dar.   Vielen Dank an Stefan Bolleininger von be-on-Quality GmbH, Marco Wanner von XITASO und Felix Winter von sepp.med gmbh für die Einblicke in bereits existierende und für Medizinprodukte abwandelbare Verfahren im Automotive-Bereich, in Software-Lösungen, mit denen man den Hürden der Regulatorik begegnen kann, sowie in Herausforderungen und Chancen bei der Nutzung von Cyber-Security in eingebetteten Systemen in Automotive und MedTech.   🗨️ Nun gehen wir zum gewohnten Austausch zwischen den Teilnehmenden und Speakern über. Bis zum nächsten Kompetenzpool Zulassung – am 📅18.09.!   Caroline Hofmann | Anna Goldsworthy | transform_EMN | Europäische Metropolregion Nürnberg | Fraunhofer IIS | Wirtschaftsförderung Nürnberg | IHK Nürnberg für Mittelfranken | IMU Institut GmbH #MedicalValley #transformEMN #AutomotiveHealth #Automotive #Diversifikation #Transformation #Zukunftswerkstatt

🎉 𝐁𝐞𝐜𝐨𝐦𝐞 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐭𝐞𝐚𝐦! 🚀 Are you looking for a new challenge and want to work in a dedicated team? We have an exciting position available and are looking for a Consultant Clinical Affairs (m/f/x)! Send us your application to [email protected] 📩 #JobOpportunity #Career #NewTeamMember #JobOpportunity #YourNewJob #JoinourTeam #beonQuality

#DMDSS 𝐃𝐢𝐠𝐢𝐭𝐚𝐥 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐬𝐮𝐦𝐦𝐞𝐫 𝐬𝐜𝐡𝐨𝐨𝐥 - 𝐌𝐲 𝐥𝐚𝐬𝐭 𝐰𝐞𝐞𝐤𝐬 𝐚𝐝𝐯𝐞𝐧𝐭𝐮𝐫𝐞 🌟 Last week, I had the opportunity to speak and discuss with the mind-blowing people in the DMD - Digital medical device Summer School in Luxembourg about HTA, reimbursement, medical science and my favorite topic #regulations. This is the second time I joined it, and it was a wonderful event with good interactions and also seeing the growth of a product, how fast an idea can pass and how to work from idea to a reasonable pitch. Good thing, it is everything from scientists, doctors and business people to create a powerful mix!🚀 Unfortunately I did not had the time to talk with everyone in depth, so I hope we all can catch up at a certain time. Big thank to EIT Health, Universität Luxemburg, IESE Business School Magda Rosenmöller, Prof. Dr. med. Jochen Klucken Shabs Rajasekharan Fozia Noor A big thanks also to Luxinnovation GIE that brought together healthtech startups and academic innovators from Luxembourg with the DMD Summer school students #dmdss #digitalmedicaldevices

🌟 𝐍𝐞𝐰𝐬 𝐟𝐫𝐨𝐦 𝐭𝐡𝐞 𝐦𝐞𝐝𝐭𝐞𝐜𝐡 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲: 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐀𝐟𝐟𝐚𝐢𝐫𝐬 𝐔𝐩𝐝𝐚𝐭𝐞 🌟 We are pleased to announce the latest edition of "𝐁𝐨𝐥𝐥𝐞𝐢𝐧𝐢𝐧𝐠𝐞𝐫'𝐬 𝐁𝐞𝐟𝐮𝐧𝐝" at DeviceMed. Stefan Bolleininger provides insights into current regulatory developments, such as the classification debate of class 1 software and new updates of MDR, transition phases of IVDR and gradual roll-out of EUDAMED. Of particular interest are the new MDCG guidelines on the clinical evaluation of orphan products. Stay informed about these important changes for innovation and compliance. You can find the full article here: https://lnkd.in/dXGmcD72 #MedTech #RegulatoryAffairs #MDR #Innovation

💼 Die be-on-Quality GmbH ist auf der Suche nach Verstärkung. Bei diesem Unternehmen unterstützen Sie Hersteller bei der Erfüllung sämtlicher regulatorischer und qualitätsmanagementbezogener 📋Anforderungen einschließlich 🏥Clinical Affairs, um deren Produkte auf den Markt zu bringen. Zusätzlich erfüllt die Schwesterfirma be-on-market alle Aufgaben als EU-Legalhersteller und Bevollmächtigter. Zur Verstärkung des Teams wird ein motivierter und erfahrener 🤝Teamplayer gesucht.   🧑💼 Consultant Clinical Affairs (m/w/d) Sie werden zur Förderung der Patientensicherheit beitragen und in der Medizinprodukteindustrie etwas bewirken: Als Regulatory Affairs Associate werden Sie eine grundlegende Rolle bei der Unterstützung des Qualitätsmanagements und der regulatorischen Prozesse spielen. Profitieren Sie von der Möglichkeit der Remotearbeit genauso wie der Zusammenarbeit im Büro – ganz nach Ihren Bedürfnissen. 👉 Hier geht es zur Stellenausschreibung: https://lnkd.in/dbxuZTha   #Jobangebot #MedicalValley #ConsultantClinicalAffairs #Consultant #ClinicalAffairs #Job #JobOffer #Karriere #Career

Are you dedicated to developing medical devices? 🏥 Are you looking for regulatory expertise?🔍 be-on-Quality is a team of highly qualified professionals with extensive knowledge in the medical device and IVD field. Tell us about your project and get your consultation now! Contact us now to discover how we can help elevate your business to the next level! 🚀 #MedicalDevices #Consulting #Innovation #Healthcare #RegulatoryCompliance

🚀 Join us at Siemens Healthineers Innovation Center on July 18th for valuable insights on regulatory and production transformations from industry experts. Stefan Bolleininger will share crucial knowledge on adapting automotive procedures to bring medical products to market efficiently. 💡 📅🔗Don't miss out - full details and registration here: https://lnkd.in/dzyFME3V

𝐖𝐡𝐚𝐭'𝐬 𝐍𝐞𝐰 𝐢𝐧 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐀𝐟𝐟𝐚𝐢𝐫𝐬 - 𝐉𝐮𝐧𝐞 𝟐𝟎𝟐𝟒 ? For a brief summary read our Regulatory Retrospective. 🔍  For details check out the latest guidelines, regulations and announcements 📜 𝐄𝐔 SCHEER UPDATE of the GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties https://lnkd.in/dQ8khBuQ MDCG 2024-10 Clinical evaluation of orphan medical devices https://lnkd.in/eJTezwxn MDCG 2022-13 Rev.1 Designation, re-assessment and notification of conformity assessment bodies and notified bodies https://lnkd.in/e3Wcf5Ad MDCG 2024-1-5 DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence https://lnkd.in/dmRiRj2G 𝐔𝐒𝐀 Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry https://lnkd.in/gNczUwNA Laboratory Developed Tests: Small Entity Compliance Guide https://lnkd.in/gJp5gXAH   🔗Follow be-on-Quality GmbH on LinkedIn to stay updated on medical device guidelines and regulations being announced. 📢 #RegulatoryAffairs #MDCG #MedicalDevice #InvitroDiagnostic #Guidelines