About Emergo Group

Emergo Group is an ISO registered medical device consulting firm with offices in North America, Europe, Asia and Australia. By focusing on providing outstanding customer service and value for our clients, we have grown to become a leading medical device regulatory consulting firm with expertise in CE Marking, US FDA submissions, Good Manufacturing Practices (GMP), ISO 13485 quality system implementation and many other areas.

Integrity - We advise clients so their business can grow. We never propose more work than is absolutely necessary, and charge a fair fee to complete that work. If we do not feel we are qualified to do a project, or we feel there is a less expensive alternative, we will inform you accordingly.

Responsibility - Clients place their trust in us to guide them through complicated regulatory processes, and represent them to governmental authorities. We work hard to represent the interests of our clients and do everything possible to ensure that medical device and IVD regulations are being met.

Experience - We have assisted hundreds of companies with implementing quality management systems or meeting international regulations. We are not a one person consultancy firm with knowledge limited to a few specialized products or areas. Our firm has experience with a wide range of devices and disciplines.

Reach - Emergo Group has numerous worldwide offices in North America, Europe, Asia and Australia. Therefore, we can support your regulatory needs in those geographic areas as you grow.

Contacts - Emergo Group is well respected in the medical device regulatory industry and stays active in several associations and technical committees. Over the years, we have made numerous contacts within government agencies, testing labs, associations and others associated with the industry. As a result, we can often expedite your road to compliance and achieve better results than might have otherwise occurred.

Please contact us for a free consultation and no-obligation proposal on CE Authorized Representative services.