ISO 13485 Medical Devices

 

Designed specifically for medical device companies, the ISO 13485 standard has many of the same requirements as ISO 9001. However, there are additional requirements that take into account the unique qualities of work within this industry. The standard is still developed in the high-level, process based framework familiar to all ISO standards, but furthers the safety and accountability needed in this dynamic sector.

 

 

Why register to ISO 13485?

 

In the current business environment, corporate accountability, responsibility and detailed risk management are critical factors in a company’s success. With multiple regulatory requirements as pre-requisites to market entry and competitiveness, medical device companies have concerns many other industries do not. By implementing the ISO 13485 standard your organization can show sound management and a proactive system, ready to navigate this complex and important business sector.

 

 

What are the benefits of ISO 13485?

 

Having your organization certified to the standard provides you, your customers, and partners a demonstrated commitment to quality and safety. Certification can lead to increased efficiencies, enhanced product quality, and improved customer and consumer service.

 

As a globally recognized standard, being ISO 13485 certified increases your organization’s credibility with potential customers and the public at large. And with many foreign markets insisting that their partners are ISO 13485 certified, your organization could gain valuable access to potential business.