ISO 13485 Consultants and Certification Consulting

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ISO 13485:2003 is a quality system standard designed specifically for medical device companies. 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 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 and Japan, ISO 13485:2003 is mandatory for Class II, III and IV medical device manufacturers (with additional requirements imposed under Canadian and Japanese law).

Watch our Flash presentation that fully explains the European CE Marking process. Requires audio.

Emergo Group, with offices in the United States, Europe, Canada, Brazil, Mexico, Russia, Australia, Japan and China, has helped hundreds of medical device and IVD manufacturers implement quality systems that meet the ISO 13485 standard. Our team of ISO 13485 consultants and Certified Lead Auditors have implemented quality management 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 meet your needs, and ensure your quality system is implemented on schedule and on budget.

Our ISO 13485 quality systems can meet all European CE Marking, 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 as your ISO 13485 consultants?

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.