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ISO 13485:2003 Consultants for Quality System Implementation

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ISO 13485:2003 is a quality system standard designed specifically for medical device companies. The standard is applied by most Class II and III (plus Class IV in Canada) medical device manufacturers to meet the quality system requirements of Europe, Canada, Australia, Japan and other parts of the world.

The ISO 13485 standard supplements ISO 9001 and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability, customer satisfaction and more. Individual countries such as Canada and Japan have additional requirements necessary to meet their specific regulations. ISO 13485 certification is not accepted by the US FDA, although it shares many of the same characteristics as FDA Good Manufacturing Practice (GMP).

Emergo Group, with offices in the United States, Europe, Canada, Australia, Japan and China, has helped hundreds of medical device and IVD manufacturers implement quality systems that meet the ISO 13485:2003 standard. Our team of ISO 13485 quality system consultants and Certified Lead Auditors have implemented ISO 13485 systems for companies manufacturing a wide range of medical devices. We will work closely with you to determine your business needs, customize a system that meets those needs, and ensure that your quality system is implemented on schedule and on budget.

Our quality systems can meet all European, Canadian, Japanese, and Australian regulations...and are FDA GMP compliant.

Although we customize our solutions to every client, all quality management systems we implement can meet the following standards and regulations:

  • ISO 13485:2003
  • CE Marking for Europe
  • US FDA Good Manufacturing Practice (GMP)
  • Canadian Medical Devices Regulations (CMDR)
  • Japan Pharmaceutical Affairs Law (PAL) and MHLW Ordinance #169
  • Australian Therapeutic Good Act regulations

Why choose Emergo Group for ISO 13485 implementation?

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

  • We fully customize our ISO 13485 quality systems for our clients.
  • Emergo quality systems can meet all requirements with regard to Europe, United States, Australia, Japan and Canada.
  • Our ISO 13485 consulting and project management team work closely 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 quality system.
  • All of our projects are based on a fixed price.

Please contact us for more information or a free proposal on our ISO 13485 consulting services.

Request a free ISO 13485 quality system implementation proposal