Regulatory and Strategic Solutions
for Medical Devices
SCC – Your Expert Partner for Approval Issues and Preparation of Documentation
Medical device regulations are becoming increasingly complex, posing a real challenge to the whole medical device industry, particularly manufacturers, importers and distributors. SCC as a service provider has been monitoring the recent developments to offer you expert advice tailored to your needs and help you prepare the required approval documents. We support both, newcomers and established companies, paying special attention to the implementation of the relevant requirements, which we have outlined for you below.
With SCC, you have a competent partner who takes care of all your scientific and regulatory needs.
Our Services at a glance
Our Services for Medical Device Manufacturers
Regulatory and strategic support for successful market access and in-market compliance
Contact Our Experts
Claudia Brakop
Senior Manager / Team Lead
Quality Management and Technical Documentation, Medical Devices
Phone: +49 671 29846-175
claudia.brakop@scc-gmbh.de
Senior Manager / Team Lead
Technical Documentation and Regulatory Affairs, Medical Devices
Phone: +49 671 29846-177
alexander.theis@scc-gmbh.de
Together with you, we develop an implementation strategy best fitted to your needs. Learn how our experts can help you to adopt the MDR requirements to your company with a minimum of effort.
Medical Devices – Latest updates
Harmonised Standards under EU MDR / IVDR: EC Publishes New Implementing Decisions (EU) 2021/1182 and (EU) 2024/817
On 8 March 2024, the EC published new implementing decisions further amending harmonised...
Read MoreMDCG 2024-1-(1-4) Guidance on the vigilance system for CE-marked devices (DSVG 01-04)
MDCG has recently published five new documents concerning Device Specific Vigilance Guidance (DSVG)
Read MoreEuropean Commission Issues Language Requirements for Medical Device Manufacturers
On 17th January 2024, the European Commission published the overview of language requirements...
Read MoreLaunching EU Dashboard Monitoring the Availability of Medical Devices and In Vitro Diagnostic Medical Devices
European Commission launches a dashboard monitoring the availability of MD and IVDR
Read MoreMDCG 2021-27, Revision 1, Guidance for Articles 13 (Importers) & 14 (Distributors)
MDCG 2021-27 guidance on the obligations of medical device importers and distributors has...
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