We are a certification company and notified body with over 20 years of experience in leveraging quality within the medical devices industry—personalized, agile, and global.
Our accredited certifications enable players in the medical device industry to expand into new markets and elevate the value of their products, processes, and quality management systems. From startups to international industry giants, we provide our clients a single point of contact for all certification needs, simplifying processes and ensuring seamless compliance. Supported by our global team of experts, we help you navigate the regulatory landscape, unlocking the full potential of your products.
Discover more about our medical device certifications: CE Marking (MDR (EU) 2017/745), MDSAP (Medical Device Single Audit Program), ISO 13485, ISO 15378, TCP III, and more.