ISO 13485 Certification
ISO 13485 is an internationally recognized Quality Management System standard that ensures the safety and quality of medical devices.
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Medical Device Services
We are active almost everywhere in the world and the members of our medical device team have extensi
Medical Device Services
We are active almost everywhere in the world and the members of our medical device team have extensi
Medical Device Services
We are active almost everywhere in the world and the members of our medical device team have extensi
Medical Device Services
We are active almost everywhere in the world and the members of our medical device team have extensi
Medical Device Services
Are you looking for a trusted partner with a deep understanding of the complex certification process for high-risk medical devices?
Do you value open and transparent communication at every step of the conformity assessment process?
Are you seeking a notified body capable of supporting advanced technologies, including rapidly evolving AI-enabled medical devices?
Above all, do you need a team that will engage in sincere dialogue, share your challenges, and work with you towards safe and timely market access?
Do you value open and transparent communication at every step of the conformity assessment process?
Are you seeking a notified body capable of supporting advanced technologies, including rapidly evolving AI-enabled medical devices?
Above all, do you need a team that will engage in sincere dialogue, share your challenges, and work with you towards safe and timely market access?
At DEKRA, meeting these expectations is our highest priority, and we deliver our services with that commitment every day.
Addressing medical device regulations is a complex and demanding process. At DEKRA, however, our knowledgeable project managers provide consistent support at every stage—from application preparation to post-market surveillance—so that clients can clearly understand each step and proceed with confidence. In addition, by conducting CE, MDSAP, and ISO 13485 audits simultaneously, we help improve audit efficiency and enable a seamless certification process.
Addressing medical device regulations is a complex and demanding process. At DEKRA, however, our knowledgeable project managers provide consistent support at every stage—from application preparation to post-market surveillance—so that clients can clearly understand each step and proceed with confidence. In addition, by conducting CE, MDSAP, and ISO 13485 audits simultaneously, we help improve audit efficiency and enable a seamless certification process.
Through ongoing dialogue with our clients, we provide a more efficient and practical certification process while maintaining the impartiality required of a notified body. With expertise covering a broad range of medical device fields—including high-risk medical devices and AI-related technologies—DEKRA serves as a reliable business partner, strongly supporting our clients in bringing their products to market.
IVDR
All in vitro diagnostic devices sold in the European Union need to have a CE marking.
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MDR
The MDR is the regulation that must be complied with when selling medical devices in the EU.
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MDSAP (Medical Device Single Audit Program)
MDSAP is an international program that enables compliance with the regulatory requirements of multiple countries through a single audit.
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