SCC - Scientific Consulting Company GmbH

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

📍 Welcome to ABIM - Annual Biocontrol Industry Meeting 2024: The highlight event opened its doors in Congress Center Basel!   With joined forces, the SCC and Ramboll team is happy to welcome you at our booth #115. Please meet our experts on site (from the left to the right): Lars Huber (SCC), Jasmin Philippi (SCC), Carla Lorenz (SCC), Joachim Rumbolz (Ramboll) Let’s meet and talk!

#MedicalDevices: MDCG revises its guidance on CAPA-Plan, including templates. MDCG 2024-12, rev. 1 is aimed at conformity assessment bodies, notified bodies, designating authorities and joint assessment teams - all actors involved in drawing up, reviewing the Corrective and Preventive Action Plan (#CAPA) as well as isssuing final opinions. Read more here 👉: https://lnkd.in/eGmS5SSk

#MedicalDevices: MDCG releases Revision 1 of the MDCG 2021-4 document summarising the new key changes to the certification process of Class D in vitro diagnostic (#ivd) medical devices under Regulation (EU) 2017/746 for manufacturers and notified bodies, and clarifying the regulatory framework. A particular focus is made on the assessment of certain elements by an expert panel and/or additional testing by an EU Reference Laboratory (EURL). Read the full summary at: 📌 https://lnkd.in/e62VMNEh #ivdr #mdr #regulatoryaffairs

We are happy to join ABIM - Annual Biocontrol Industry Meeting 2024! Drop by at our Booth #115 & meet our regulatory experts Carla Lorenz, Jasmin Philippi and Lars Huber. We are excited about joining forces with Ramboll and welcoming our new colleague Joachim Rumbolz to our ABIM team. Let's meet in Basel soon!

Exciting news! We’re thrilled to announce that SCC has joined forces with global engineering, architecture and consultancy company Ramboll! This acquisition will provide great opportunities to our team to deliver through a global platform while also complementing and enhancing Ramboll’s health sciences expertise.   Together, Ramboll and SCC aim to play a leading role in the European and global product safety and regulatory affairs market and enable our clients to protect biodiversity and natural resources through sustainable solutions. Ramboll and SCC are a perfect match”, says our Managing Director Florian Pistel. "We can provide greater career opportunities for our talented employees.” Managing Director Monika Hofer adds: “Ramboll provides a true global platform from which to practice and collaborate, across the Americas, Europe, and APAC. We share a common mission, purpose and culture: science-based consulting and delivering the best solutions to our clients.” We’re very much looking forward to the future with Ramboll. Read more here 👉 https://lnkd.in/ejSJGsFJ #healthsciences #agrochemicals #medicaldevices #biocides