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
Team NB Publishes Press Release on Certificates with Conditions
On 12 March 2025, the TEAM NB issued a press release on certificates...
Read MoreISO 15223-1 First Amendment Published
The harmonized standard ISO 15223-1 defines the symbols used by medical device manufacturers...
Read MoreUpdate on the Medical Devices Operator Ordinance (MPBetreibV) and Medical Devices Dispensing Ordinance (MPAV)
Germany amends the Medical Devices Operator Ordinance (MPBetreibV) and Medical Devices Dispensing Ordinance...
Read MoreNew Regulation (EU) 2025/40 on packaging and packaging waste
The EU adopts a new Regulation (EU) 2025/40 on packaging and packaging waste,...
Read MoreMDCG guidance alert: New MDCG 2024-16 guidance on how to deal with interruption or discontinuation
New MDCG guidance provides an information form for MD and IVD manufacturers to...
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