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ISO 13485 - QMS for Medical Device Manufacturers

ISO 13485:2003 is a quality system standard designed specifically for medical device companies. The ISO 13485 standard has many of the same requirements as ISO 9001. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.

ISO 13485 is the most commonly chosen path for medical device companies to meet the quality system requirements in Europe, Canada, Japan, Australia and other countries. Although implementing ISO 13485 is voluntary for manufacturers selling in Europe, most companies opt to apply this standard to demonstrate compliance with the Directives. In Canada, ISO 13485:2003 is mandatory for Class II, III and IV medical device manufacturers (with additional requirements imposed under Canadian law). Compliance with Japan's Ministerial Ordinance #169 is quite similar to ISO 13485 with additional requirements imposed under Japan law.

Advantages of ISO 13485 certification:

As we mentioned, ISO 13485 certification is not mandatory in most markets. Here is how your company can benefit from ISO 13485:2003 certification: :

• Compliance with European standards offers straightforward access to the Japanese, Australian and New Zealand markets
• Other countries around the world also recognize ISO 13485 as a means of meeting their quality requirements
• ISO 13485 is a globally recognized standard and having this certification will increase the credibility of your company with potential customers.
• Certification can lead to increased efficiency, better product quality, and improved customer service within your company
• Demonstrate your consumers and partners a commitment to quality

Why choose Euroglobal as your ISO 13485 consultant?

Euroglobal has helped hundreds of medical device and IVD manufacturers implement quality systems that meet theISO 13485 standard. Our team of experienced ISO 13485 consultants have implemented numerous quality management systems for companies manufacturing a wide range of medical devices.

Our system has been proven to work efficiently and we have been through the process with many medical device and IVD companies that we guarantee you will pass your first ISO certification audit if you follow our plan.

• Our ISO 13485 consulting and project management teams will work closely with you to ensure that your quality system is implemented on time and on budget.
• On-site ISO 13485, CE Marking, and Canadian Medical Devices Regulations training for your key employees is included in the cost of an Emergo Group quality system.
• All of our projects are based on a fixed price.