More than the sum of single services
gempex and SCC are trusted partners who complement each other by sharing their tasks depending on which job fits in better with which portfolio. Both partners perfectly understand the needs of their customers looking for competent and individually tailored solutions, often at short notice. With a primary focus on the quality and efficiency of services paired with the mutual exchange of knowledge, gempex and SCC are best fitted to help their customers meet their challenges.
And this is the driving force behind the partnership, a one-stop-shop providing effective solutions for the medical device industry ranging from detailed expertise to flexible implementation of various tasks within the life cycle of medical devices – from the conceptual stage, product planning and design, development and implementation, to valid production, placing on the market and finally post market surveillance.
Strong partners with distinct areas of expertise
gempex assists its clients in implementing ISO 13485 and EU MDR, developing quality assurance systems and preparing and guiding through national and international inspections. gempex has special expertise in the field of combination products, which have many point of contact to the traditional tasks of the Good Manufacturing Practice.
SCC provides comprehensive regulatory and scientific expertise by supporting its clients throughout the life cycle of medical devices, including concept and product development, compliance with most recent requirements and performance validation (biological and clinical evaluation), technical documentation and post market surveillance following EU MDR, US FDA and other regulations.
From customer challenges to common tasks and viable solutions for medical devices
The competent specialists or experienced medical device specialist teams will find solutions to any challenge in the life cycle of a medical device.
With more than 80 employees in Germany, Switzerland and China, gempex has been providing support for the implementation, optimization and maintenance of quality assurance systems in the life science industries for more than 20 years.
As a professional home for more than 160 regulatory experts, SCC supports the industry with tailored strategic solutions for their regulatory and scientific needs, with a major focus on international registration and in-market compliance services.
Alongside consulting services and strategic advice, gempex and SCC organize training and coaching workshops, help their customers carry out their tasks in person or remotely.
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