#medicaldevices: New MDCG 2024-10 report on clinical evaluation of orphan medical devices available Read more at: https://lnkd.in/eDChZ9Br #clinicalevaluation
SCC - Scientific Consulting Company GmnbH
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 GmnbH
- 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
Wegbeschreibung
Am Grenzgraben 11
Bad Kreuznach, 55545, DE
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Wegbeschreibung
Friedrichsstraße 40
Berlin, 10969, DE
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Wegbeschreibung
8F Tri-Seven Roppongi
7-7-7 Roppongi, Minato-ku
Tokyo, 106-0032, JP
Beschäftigte von SCC - Scientific Consulting Company GmnbH
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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
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Marla Xhani
PhD, PharmaD - Regulatory Toxicologist
Updates
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New trends in biological evalutation of #medicaldevices: The standard EN ISO 10993-1 is currently under revision with several important amendments being proposed. Read more about the changes to come at: https://lnkd.in/edVQFypu #biologicalevaluation
Trends in Biological Evaluations: New Draft Version of EN ISO 10993-1
https://scc-medical-devices.com
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European Commission updates Guideline MDCG 2022-4 on appropriate surveillance of the transitional provisions regarding devices covered by certificates under the MMD and IVDD: https://lnkd.in/eGxi3B96 #medicaldevice #regulatorycompliance #regulatoryaffairs
EC updates Guideline MDCG 2022-4
https://scc-medical-devices.com
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#UKREACH: #Defra releases proposal for Alternative Transitional Registration Model (ATRm). The proposal is open for public consultation until 11 July 2024. Further details can be found at: https://lnkd.in/eGB9_qMU
UK REACH: Defra releases proposal for alternatove transitional registration model
scc-gmbh.de
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#euparliament approves the proposal for the gradual introduction of #EUDAMED, the transitional arrangements for #IVDs and obligation to report supply disruptions. Read more at: https://lnkd.in/ebwr97hT #medicaldevices #regulatorycompliance #mdr #ivdr
Amendment Proposal of MDR and IVDR: EU Parliament Approves Proposed Measures
https://scc-medical-devices.com
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#europeancommission issued guiding criteria and principles for the essential uses of the most harmful #chemicals allowing them only when their use is necessary for health and/or safety and/or critical for the functioning of society and when there are no acceptable alternatives. Read more here: https://lnkd.in/dTXT-tzS #chemicalsregulation #chemicalscompliance #regulatoryaffairs #harmfulchemicals
European Commission Issued Guiding Criteria and Principles for the Essential Use Concept
scc-gmbh.de
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We're #hiring a new Senior Toxicologist (m/f/d) in Bad Kreuznach, Rhineland-Palatinate. Apply today or share this post with your network.
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We're #hiring a new IT-Desktopsupport in Bad Kreuznach, Rhineland-Palatinate. Apply today or share this post with your network.
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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.
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We're #hiring a new Ecotoxicologist or Environmental Scientist (M/F/D) - Regulatory Affairs in Bad Kreuznach, Rhineland-Palatinate. Apply today or share this post with your network.