ISO 13485

ISO 13485 is an international standard that specifies requirements for medical device manufacturers. ISO 13485: 2003 has been harmonized against the three Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices). The main difference between ISO 9001 and ISO 13485 is that ISO 13485 is more focused towards ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement. Once you implement processes and procedures that comply with the requirements listed in ISO 13485:2003.
ISO 13485 is becoming widely accepted as the international standard to address medical device regulations around the world.

• Increased efficiency
• Cost savings
• More effective risk management and quality assurance
• An improved ability to respond to customer requirements are just a few of the potential results that certification to the standard can bring.
• Certification to ISO 13485 satisfies a significant portion of the EU Directive requirements for marketing medical devices in Europe.