#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
SCC - Scientific Consulting Company GmbH
Chemische Produktion
Regulatorische und wissenschaftliche Beratung
Info
Willkommen bei der SCC GmbH: Wir sind eines der größten Beratungsunternehmen Europas auf dem Gebiet der Regulatorik, angesehener Partner der Chemieindustrie – und das berufliche Zuhause von über 160 Experten verschiedenster Nationalitäten. Unsere Leidenschaft: das Management von Registrierungs- und Zulassungsverfahren für Chemikalien wie Agrochemikalien, Pflanzenschutzmittel, Biozide und Co. Unser Ziel: weiter zu wachsen. In einem internationalen Kundenumfeld. In der persönlichen, offenen Arbeitskultur eines Familienunternehmens, das sich entschlossen um sein Team kümmert. Neben unserem Hauptsitz in Bad Kreuznach inmitten der naturnahen Rhein-Nahe-Region haben wir Niederlassungen in Berlin, Großbritanien und Japan.
- Website
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http://www.scc-gmbh.de
Externer Link zu SCC - Scientific Consulting Company GmbH
- Branche
- Chemische Produktion
- Größe
- 51–200 Beschäftigte
- Hauptsitz
- Bad Kreuznach
- Art
- Privatunternehmen
- Gegründet
- 1989
- Spezialgebiete
- Scientific Consultancy, Market Authorisation, (European) Regulatory Affairs, Study Monitoring, (GLP) Archiving, International regulatory compliance, Dossier preparation, submissions, defence, Plant protection, Chemicals, Biocides, Medical Devices, FCM, Cosmetics, Feed additives, Pharmaceuticals, Plant health and nutrition, Modelling and risk assessment, Environmental exposure and EcoTOX, Human health assessments, Maximum Residue Levels und Efficacy and product performance
Orte
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Primär
Am Grenzgraben 11
Bad Kreuznach, 55545, DE
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Friedrichsstraße 40
Berlin, 10969, DE
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14F Hibiya Central Building
1-2-9 Nishi Shimbashi, Minato-ku
Tokyo, 105-0003, JP
Beschäftigte von SCC - Scientific Consulting Company GmbH
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Martin Nussbaumer
Director at Scientific Computing Center (SCC)
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Regina Stabbert
Biocides | Global Registrations | ED Assessment | Human Health Risk Assessments
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Mathias Rietzel-Roehrdanz
Senior Manager Regulatory Affairs Chemicals & Consumer Products bei SCC – Scientific Consulting Company GmbH
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Henry von Rège
Senior Manager bei SCC – Scientific Consulting Company GmbH
Updates
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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!
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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
SCC Joins Forces with Ramboll
scc-gmbh.de
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SCC - Scientific Consulting Company GmbH hat dies direkt geteilt
#EUROTOX: Meet SCC at the upcoming EUROTOX congress in September 2024 Copenhagen, Denmark | 8-11 September 2024 Our experts look forward to meeting you at EUROTOX 2024: https://lnkd.in/eVQMKaz9 #meetus
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Medical Devices News: Germany issues a new guideline on fundung for clinical validation of innovative medical technology solutions. Read more at: https://lnkd.in/dPFbfFxW
New BMBF funding guideline for “clinical validation of innovative medical technology solutions” in Germany
https://scc-medical-devices.com
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Sustainable Pesticide Use in EU – Quo Vadis? In their article published in 2024 Biologicals Special Magazine (AgroPages), our regulatory experts explore the topic of biologicals and the intricacies associated with them, such as existing regulatory requirements, efficacy issues and the use of biologicals in IPM, summing this up with an outlook for the future. Interested to find out more? – Then follow the link: https://lnkd.in/eR7hvhCs
Sustainable Pesticide Use in EU – Quo Vadis?
scc-gmbh.de
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We're #hiring a new Project Manager (m/f/d) - Regulatory Affairs in Bad Kreuznach, Rhineland-Palatinate. Apply today or share this post with your network.
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We're #hiring a new Microbiologist (m/f/d) - Regulatory Affairs in Bad Kreuznach, Rhineland-Palatinate. Apply today or share this post with your network.
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Go Live for 'swissdamed': #Switzerland launches the first module of its medical device database, starting with the registration of companies and economic operators on 6 August 2024. Module 2 for the product registration will be available from 2025, initially on a voluntary basis. Read further at https://lnkd.in/e9yCG3uA #medicaldevices
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We're #hiring a new Archiv-Manger für GLP und regulatory Archiving (M/W/D) in Bad Kreuznach, Rhineland-Palatinate. Apply today or share this post with your network.