SCC - Scientific Consulting Company GmbH

Thank you for joining us at MEDICA - Leading International Trade Fair- and COMPAMED – Düsseldorf / Deutschland 2024! Now that the exhibiton is over and everyone is back in the office, we are exhausted but delighted to have had the opportunity to reconnect with our customers, partners and stakeholders, but most importantly, to meet new customers from around the world and learn about their innovative products. Over the past four days, we have been able to share the latest news and trends, discuss current industry issues, regulatory challenges, recent developments and the future of #medicaldevices and in vitro diagnostics (#IVD). In view of joining forces with Ramboll Management Consulting, we introduced Ramboll to our customers as their new regulatory partner in the near future. We were happy to receive positive and welcoming responses.    We also enjoyed the programme presented by our partners in the field of clinical trials from Mainz (MIC - Medical Device Innovation Center Mainz), in particular Karolina Nadjafi & Michael Dr. Hopp. Here, we were able to learn more about the driving forces of innovation in our region.   We look forward to staying in touch and continuing to advise you on all aspects of #technicaldocumentation and #conformityassessment, market authorisation and in-market compliance for your medical devices and in-vitro diagnostics. Please don't hesitate to get in touch 👉 : https://lnkd.in/e-kxQ-mP Your SCC-Ramboll team Here are some impressions from MEDICA-COMPAMED 2024: - Meet our team of regulatory experts: Rene Weber, Alexandra Busley, Claudia Brakop, Valerie Osieka, Alexander Theis (not shown) together with our partner Hao Zhang - Rich Hughes from Cerca Biotech - The Rhineland-Palatinate booth with Daniela Schmitt and the MIC representatives

Join our Ramboll and SCC's unified team of #regulatory experts at Biocides Europe 2024 (Chemical Watch news & events by Enhesa): 📍 Vienna, Hilton Vienna Park + Virtual 📅 2-3 December 2024 #healthsciences #biocides #regulatorycompliance https://lnkd.in/eFXw4NEY

#MedicalDevices: the Medical Device Coordnination Group has recently published a revised version of its guidance MDCG 2022-5 Rev. 1 on #BorderlineProducts. The guideline aims to improve classification of borderline products with new examples and explanations. Are you interested to learn more about the revised document? – Please go to: 👉 https://lnkd.in/ePuywZ93 If you have any questions about the classification of your products, please constact our experts. They will be happy to help: 👉 https://lnkd.in/e-kxQ-mP   #regulatoryadvice #regulatorycompliance #mdr #ivdr

Welcome to MEDICA - Leading International Trade Fair and Compamed: 📍 Düsseldorf 📅 11 – 14 November 2024 Today is the first day of the #tradefair. SCC is delighted to be exhibiting in Düsseldorf and looks forward to the next 4 days of business meetings and insightful discussions, sharing our skills and expertise in #regulatoryaffairs with our clients and prospects. Visit our 🤝Booth K34/ Hall 8B if you are looking for a professional advice on #TechnicalDocumentation to make you your #MedicalDevices or #IVDs fit for the #ConformityAssessment and #MarketApproval or #InmarketCompliance. Join our team in Düsseldorf: Claudia Brakop, Alexandra Busley, Rene Weberé Weber, Alexander Theis, Valerie Osieka We look forward to seeing you in Düsseldorf! Stop by at our booth and let’s talk! https://lnkd.in/ej28x7nc

#MedicalDevices: Ethylene Oxide (EtO) is now within the scope of the MDR/ IVDR. The MDCG Group recently provided guidance on the regulatory requirements for ethylene oxide (EtO) applied for sterilisation of medical devices (#md), in vitro diagnostics (#ivd) and medicinal products. Read more at our website: 👉 https://lnkd.in/ekKMPiRD or get in touch with our experts directly: 👉 https://lnkd.in/e-kxQ-mP #regulatoryadvice #regulatoryservices

Ukraine adopts regulation on chemical safety, Ukraine REACH In July 2024, the Ukrainian government formally approved Law No. 2804-IX, the technical regulation on ensuring chemical safety and management of chemical products. The Ukraine REACH regulation (or UA REACH) follows the example of EU REACH and will come into force on 23 January 2025, six months after its approval. Interested to find out more? – Visit our website to read the news on UA REACH 👉 https://lnkd.in/edFUA5Gd Or reach out to our experts directly 👉 https://lnkd.in/e-h8r6HB #REACH #ChemicalsRegulation #UAREACH

MEDICA-COMPAMED 2024 - MEDICA - Leading International Trade Fair 📍 Düsseldorf, Germany | 11 -14 November Join our SCC team at COMPAMED – Düsseldorf / Deutschland! Visit our Booth #K34/Hall 8B (https://lnkd.in/eP9q4CtN) and meet our regulatory experts on site: Alexandra Busley, Alexander Theis, Claudia Brakop, Rene Weber and Valerie Osieka. Our team will be happy to advise you on how to bring your #MedicalDevices and In-Vitro Diagnostics (#IVD) to the market in a safe, efficient and sustainable way. See you in Düsseldorf! #regulatoryaffairs

#TeamNB publishes press release on the transition to the implementation of Class D #IVDs oversight by EU reference laboratories Class D in vitro diagnostic medical devices must be tested by EU reference laboratories designated by the European Commission in line with Article 100(4) #IVDR. In its press release, the Team NB focuses on the impact on the conformity assessment of Class D devices. This primarily has an effect on performance and batch verification. 👉 Visit our website to read the summary of the key points published in the press release: https://lnkd.in/eUwQUvwp #medicaldevices #regulatoryaffairs #regulatorycompliance #mdr

ABIM - Annual Biocontrol Industry Meeting 2024 – Wrapping up One day after the official ending of ABIM 2024, we are still excited to have been part of this major global #biocontrol event again this year.   A BIG Thanks to the ABIM team for a successful event, providing a platform for cutting-edge presentations, insightful discussions and exchange among stakeholders.   Thanks very much also to all ABIM participants who joined the SCC-Ramboll team at our booth to share their thoughts with us, exchange their opinions on what works for them, and voice their needs and challenges as we move together towards a more #SustainableFuture of European and global agriculture.   Let’s #CloseTheGap together and stay in touch! Please feel free to contact us 👉 https://lnkd.in/exZeqSQ9 any time you need our advice or reach out to us on LinkedIn: Jasmin Philippi, Carla Lorenz and Joachim Rumbolz #sustainability #IPM

#Medicaldevices: Revised guidance on application of MDR requirements von legacy devices On 16 October, the Medical Device Coordination Group (MDCG) published the revised guidance 2021-25 Rev.1 on the application of MDR requirements to legacy devices. The guidance provides orientation for manufacturers of legacy devices who market their products under the Medical Device Regulation (MDR). Specifically, the annex of MDCG 2021-25 Rev. 1 offers a non-exhaustive list of the MDR requirements applicable to legacy devices. #mdr #regulatorycompliance #regulatoryservices Feel free to reach out to our experts if you have any questions regarding the revised guidance or need professional advice on how to ensure safety and market compliance of your legacy devices. 👉 https://lnkd.in/eEPS7fwk