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 Regulatory Affairs – Medical Devices, Quality Management & Technical Documentation
Phone: +49 671 29846-175
claudia.brakop@scc-gmbh.de

Dr Alexander Theis
Senior Manager Regulatory Affairs – Medical Devices, Regulatory, Scientific & Technical Services
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
MDCG 2020-3 Rev.1: Guidance on significant changes to transitional provisions under Article 120 MDR revised
MDCG 2020-3 Rev. 1: Guidance on significant changes to transitional provisions under Article...
Read MoreTeam-NB publishes best practice guidance for the submission of technical documentation for IVD MD
Team-NB publishes best practice guidance for the submission of technical documentation for IVD...
Read MoreTeam-NB revises the best practice guidance for the submission of technical documentation for medical devices
Team-NB revises the best practice guidance for the submission of technical documentation for...
Read Moregempex and SCC– partnership for medical device industry
More than the sum of single services
Read MoreEuropean Commission extends MDR transition period
On 7 March 2023, the EU Council adopted the Commission's proposal granting notified...
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