DAVE Embedded Systems Now ISO 13485 Certified for Medical Applications

Author: Laura Biddiscombe

We are pleased to share some exciting news with you - DAVE Embedded Systems has just been certified ISO 13485.

ISO 13485 2003 is the quality management standard for medical devices which specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet both customer requirements and regulatory requirements applicable to medical devices and related services.

The ISO 13485 standard was developed to facilitate harmonized medical device regulatory requirements for quality management systems. In Europe, ISO 13485 (or EN ISO 13485) is seen as the standard for the medical device industry. Based on the ISO 9001 standard, ISO 13485 was first introduced in Europe in 1996. Although ISO 13485 certification is voluntary, achieving it allows you to meet the quality system requirements of various medical directives with much less difficulty.

Download the DAVE Embedded Systems ISO 13485 declaration in PDF format - DOWNLOAD

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The DIVA  is a CPU module based on the Texas Instruments "Sitara" AM335x Cortex-A8 application processor. It is built with SO-DIMM 204 pin form factor and it offers lots of graphics, processing, peripherals and industrial interface options, allowing customer to implement cost-effective designs.

• ARM Cortex-A8 architecture @ up to 720 MHz
• NEON Multimedia Coprocessor and PowerVR® SGX Graphics Engine
• Dual Programmable Real-Time Unit and Industrial Communication Subsystem
• Crypto Hardware Accelerator
• Interfaces including Dual CAN and Ethernet

Download DIVA Datasheet 
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