Emergo Group specializes in helping dental and medical device companies obtain regulatory approval to sell their products in the US and international markets.

The company has has offices in the US, Canada, Europe, Asia and Australia and was founded in 1997. DTA members receive a 10% DISCOUNT on all Emergo services and receive a free initial consultation. You must mention that you are a DTA member to receive the discount. Please ask for Ian Gordon or Rene van de Zande when contacting Emergo.

SERVICES FOR USA - www.emergogroup.com/services-by-region/usa

• FDA 510(k) submissions - Emergo prepares the documentation that will clear your dental device for sale in the US.
• FDA GMP consulting - Help complying with the FDA's Good Manufacturing Practices requirements.
• Distributor search - Emergo can find and qualify new regional distributors for your products.

• CE Marking consulting - Help obtaining the CE Marking so you can export to Europe.
• EU Authorized Representative - Needed before you can export to Europe.
• Technical File preparation - Documentation that proves safety and efficacy of your device.
• ISO 13485 consulting - Emergo can help you implement a new quality management system, if required.
• Dental distributor search in Europe - Find distributors in any European country.

• Medical device license - Assistance preparing the documentation need to obtain regualtory approval from Health Canada.
• ISO 13485:2003 - Emergo can implement or modify your quality management system to meet Canadian regulations.
• Distributor search - Find, quality and manage dental distributors in Canada.