Gempex and SCC – a partnership for the medical technology industry

A full-service offering for all topics throughout the lifecycle of medical devices
For every task the right partner
One-Stop-Shop for the medical device industry

Together more than the sum of individual services

gempex GmbH and SCC Scientific Consulting Company GmbH are trusted partners who repeatedly hand over tasks that better fit the other's portfolio, confidently and reliably. Entirely in the spirit of customers seeking expert solutions for their specific challenges, often under time pressure. Being able to competently and promptly address inquiries at any time corresponds to our shared quality standard. And thanks to short communication channels for mutual exchange, customer needs can be reliably and securely met.

For this reason, SCC and gempex have established a partnership that, as a One-Stop-Shop, offers comprehensive services in the field of medical devices for your clients. The range of services extends from highly competent consulting to flexible implementation of all topics related to the lifecycle management of medical devices – from the concept phase through product planning, design, development, and implementation into valid production, market approval, and post-market surveillance.

Each partner has its strengths

Thus, gempex supports clients in implementing ISO 13485 and the EU MDR, in establishing efficient quality assurance systems, and in preparing and accompanying national and international inspections. Special expertise also lies in the field of combination products, which have many touchpoints with traditional Good Manufacturing Practice (GMP) tasks.

SCC possesses expertise in all regulatory and scientific areas and advises clients on questions ranging from the conception and planning of product development, implementation of development requirements, and development validation (biological assessment, clinical evaluation) to technical documentation, declaration of conformity, and post-market surveillance according to EU MDR and regulations of other countries and regions.

Overcoming challenges together

Competent specialists or experienced implementation teams are available for all tasks throughout the lifecycle of a medical device.

gempex has been based in Germany, Switzerland, and China for over 20 years, supporting projects in the life sciences with more than 80 employees. With a team of over 160 experts, SCC supports the industry with tailored solutions in regulatory affairs and science, with a focus on international approvals and compliance with regulatory market requirements.

gempex and SCC jointly advise, develop strategies, train and coach, and implement tasks directly on-site or remotely with clients.

For inquiries, the gempex expert team in Mannheim is available via contact@gempex.com, and the SCC Scientific Consulting team in Bad Kreuznach via info@scc-medical-devices.com.