Elemaster Group is pleased to announce the successful renewal of its ISO 13485:2021 certification for the Italian sites: Elemaster Headquarters, Elemaster Prototypes, and Eletech, the lead company of the International Design Centres (IDCs), the R&D division of the Group.
This milestone reaffirms the Group’s long-standing commitment to quality and regulatory compliance in the design and manufacturing of medical devices. In a sector where safety, traceability, and reliability are non-negotiable, ISO 13485:2021 stands as a critical requirement to support Customers at every stage of the product lifecycle.
Globally, this certification is hold by Elemaster Shanghai and Elemaster US too, reflecting Elemaster’s global consistency in applying harmonised standards across its international locations, meeting the complex needs of multinational Customers operating in the Medical & Healthcare sector.
Thanks to its integrated service model, Elemaster covers the full spectrum of electronic product development: from Research & Development, design and certification, to PCB and wiring harnesses manufacturing, rapid prototyping, serial production, mechanical integration, logistics, and after-sales support.
This end-to-end approach enables Elemaster to serve as a strategic partner in the development of high-performance, compliant medical technologies that meet the most stringent global standards.
Explore all certifications held by Elemaster Group across the sectors it serves, click here.