GMED is a Notified Body (number 0459) and international certification body that provides conformity assessment services for the medical device industry. The organisation's core function is to verify that manufacturers meet regulatory compliance and safety standards required for market access, with the stated aim of protecting patients and users globally.
The company's technical scope covers medical device certification, conformity assessment, and quality management systems. Its service portfolio includes CE marking for European market access, ISO 13485 quality management certification specific to medical devices, and Medical Device Single Audit Program (MDSAP) auditing across five countries. GMED operates across Europe, Asia, and North America, supported by a team of 350 dedicated experts and more than 30 years of experience in the field.
As an organisation engaged in regulatory assessment, GMED emphasises integrity and independence in its operations. Its work sits at the intersection of engineering, quality systems, and healthcare regulation - domains where technical rigour and adherence to established standards are central to the certification process.
