Quality System

A quality system is reflective of the standards adopted by an organization. At eDevice, our quality system is certified to medical standards (ISO 13485), required by stringent quality agreements requested by our healthcare customers.

Our ISO 13485 certificate covers the complete eDevice’s offer, including hardware, software, network services and data transmission, as follows: DESIGN, PRODUCTION, MARKETING OF MODEMS, COMMUNICATION EQUIPMENT AND REMOTE PATIENT MONITORING EQUIPMENT. PROVISION OF GLOBAL NETWORK TELECOMMUNICATION AND DATA TRANSMISSION SERVICES.

We manage system developments from initial requirements to final production review with a continuous ISO 14971 risk management process. Our Regulatory department monitors thoroughly the new standards related to privacy (GDPR, HIPAA) and medical device approvals (CE, FDA).

Software development follows IEC 62304 development methodology and once on the market, Post Market Surveillance operates throughout the lifetime of the products.