gempex and SCC – Partnership for Medical Device Industry
18 April 2023
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 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 related 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.
gempex is an independent, international service provider offering professional advice and assistance in meeting regulatory requirements in the life science branch. Headquartered in Mannheim, Germany, gempex also has its offices in Sisseln, Switzerland, and Guangzhou, China.
From 15 experts at the foundation in 2002, the global gempex team has grown to more than 80 members specialized on developing, maintaining and optimizing quality assurance systems in life sciences.