About Emergo Group

Emergo Group is an ISO registered medical device consulting firm with offices in the United States, Canada, Mexico, The Netherlands, France, China, Japan and Australia. By focusing on providing outstanding customer service and value for our clients, we have grown to become one of the leading ISO 13485 consultants (and GMP) with additional expertise in CE Marking, Canadian licensing, China SFDA registration, Japanese device approval and many other areas. You can read detailed resumes/CVs for all of our quality system consultants on our main website at EmergoGroup.com

Why medical device and IVD companies choose Emergo Group:

Integrity – Clients place their trust in us to guide them through complicated regulatory processes and we take that responsibility very seriously. We never propose more work than is absolutely necessary, and charge a fair fee to complete that work. We take pride in the fact that a significant portion of our business comes from existing clients.

International Reach – No other medical device consulting firm in the world can help you access as many international markets as Emergo Group. We know how create a single quality system for you that will meet all of the requirements in the US, Europe, Japan, China, Australia, Canada and other markets worldwide.

Fixed Fee Pricing – We have completed ISO 13485 implementation and consulting projects for hundreds of medical device companies around the world. This experience allows us to price our ISO 13485 consulting implementations on a fixed fee basis plus actual travel expenses. You will know exactly how much the project will cost before you begin. No surprises.

Experience – Hundreds of medical device and IVD manufacturers depend on us for advice on international regulations related to the USA, Europe, Canada, Mexico, Russia, Japan, China and Australia. Our medical device consulting team has diverse experience with a wide range of devices and disciplines. Many of them are Certified Lead Assessors and experienced regulatory affairs professionals who have been involved in developing, implementing, training and auditing organizations to numerous ISO standards and regulatory requirements.

Industry 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, Notified Bodies, testing labs, associations and others associated with the industry. As a result, we can often expedite your path to ISO 13485 compliance and achieve better results than might have otherwise occurred.

See why hundreds of companies worldwide depend on Emergo Group. Contact us for more information or a free proposal today.