Regulatory and Strategic Solutions
for Medical Devices
SCC – Your Expert Partner for Approval Issues and Documentation Preparation
Medical device regulations are becoming increasingly complex, posing a real challenge to the whole medical device industry, particularly manufacturers, importers and distributors. Ramboll 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 us, you have a competent partner who takes care of all your scientific and regulatory needs.
Our Services at a glance
Our Expertise for the medical device branch
Further health sciences areas of Ramboll
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 1512 8085895
claudia.brakop@ramboll.com
Senior Manager / Team Lead
Technical Documentation and Regulatory Affairs, Medical Devices
Phone: +49 170 4173178
alexander.theis@ramboll.com
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
EUDAMED: First four modules confirmed operational
On 27 November 2025, the EC published Decision (EU) 2025/2371, confirming the functionality...
Read MoreNew ISO 10993-1:2025 Standard for Medical Device Biological Evaluation Released
New MD biocompatibility standard, ISO 10993-1:2025, helps manufacturers identify, assess, and manage biological...
Read MoreLet’s meet at MEDICA-COMPAMED 2025
Let's meet at MEDICA-COMPAMED 2025 in Dusseldorf from 17-20 November
Read MoreUpdated Manual on Borderline and Classification for Medical Devices Released
The fourth version of the 'Manual on Borderline and Classification for Medical Devices...
Read MoreFuture restrictions on PFAS and current regulatory activities from FDA and EU REACH
PFAS in medical devices, typically large-molecule materials known as fluoropolymers, garnered significant public...
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