Emergo Group Inc

our firm reach out to Emergo for QMS compliance assistance. keep in mind that for their QMS consulting service, it is country based. what they office in other international countries may not be available for US companies. we specifically use them for FDA QSR consulting for medical devices and IVDs. their consulting team is extremely knowledgeable in this area with extremely fast turnaround time and responsiveness. they provide a single point of contact which increases efficiency and decrease confusion and miscommunication. we have been highly satisfied with the consulting solutions Emergo provides and will contact to use their service

Strengths: regulatory consulting, QMS compliance, clinical, medical device regulation

Needs to improve: none

We have used Emergo to assist in medical device registration and approval in Australia, and to provide information on regulatory pathways in various countries for our unique medical device technology. The consultants that worked with us were a pleasure to interact with and provided useful information.

Strengths: They offer medical device consulting expertise in various International markets, and have in-country representatives (which is often required) in many OUS countries. They have knowledgeable and experienced consultants for the medical device industry.

Needs to improve: none encountered