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
SCC team at MEDICA-COMPAMED 2023
Thank you for joining us at MEDICA-COMPAMED 2023
Read MoreMDCG 2023-4 Guidance for Medical Device Software (MDSW) – Hardware combinations published
MDCG 2023-4 guidance was published on 18 October 2023
Read MoreNew ISO 10993-17:2023 available defining the toxicological risk assessment of medical device constituents
New ISO 10993-17:2023 available defining the toxicological risk assessment of medical device constituents...
Read MoreUS-FDA publishes a revised guidance “Use of International Standard ISO 10993-1”
On September 8, the FDA published an update of the document “Use of...
Read MoreTeam NB publishes position paper on transfer agreement for surveillance of legacy devices
On 14 August, Team-NB published the position paper on transfer agreement for surveillance...
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