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 Expertise for the medical device branch

Further Regulatory Areas of SCC

Our Services for Medical Device Manufacturers

Regulatory and strategic support for successful market access and in-market compliance

Quality Management

Quality Management for the
Medical Device Industry

Risk Assessment

Risk Assessment of Medical Devices

Biocompatibility

Biological Evaluation of Medical Devices

Substances of Concern

Substances of Concern and Nanomaterials

Clinical Evaluation

Clinical Evaluation Services for Medical Devices

Qualification & Validation

Qualification and Validation for the Medical Devices Industry

Contact Our Experts

Claudia Brakop
Senior Manager Regulatory Affairs – Medical Devices, Quality Management & Technical Documentation

Tel: +49 151 28085-895
claudia.brakop@scc-gmbh.de

Dr Alexander Theis
Senior Manager Regulatory Affairs – Medical Devices, Regulatory, Scientific & Technical Services

Tel: +49 671 29846-177
alexander.theis@scc-gmbh.de

Dr Martin Weiser
Managing Director/Head of Pharmaceuticals and Medical Devices

Tel: +49 671 29846-112
martin.weiser@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.

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