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
ed.hbmg-ccs@pokarb.aidualc
Senior Manager / Team Lead
Technical Documentation and Regulatory Affairs, Medical Devices
Phone: +49 671 29846-177
ed.hbmg-ccs@sieht.rednaxela
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 2021-25 Rev. 1: MDCG publishes revised guidance on the application of MDR requirements to legacy devices
MDCG revises its guidance on the application of MDR requirements to legacy devices
Read MoreMDCG 2024-12 Rev. 1: MDCG revises its guidance on CAPA plan assessment
MDCG revises its guidance on corrective and preventive action plan assessment, including templates
Read MoreMDCG 2021-4 Rev. 1: How to apply transitional provisions for certification of class D IVD
MDCG releases Revision 1 of the MDCG 2021-4 document
Read MoreCorporate News – SCC Joins Forces with Ramboll
We are pleased to announce to have joined Ramboll, the global engineering, architecture...
Read MoreNew BMBF funding guideline for “clinical validation of innovative medical technology solutions” in Germany
Germany issues a new guideline on funding for clinical validation of innovative medical...
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