Medical Device Consultants and Consulting Services
Emergo Group offers medical device and IVD companies a wide array of quality assurance and regulatory compliance services through its offices in the United States, Europe, China, Australia and Canada. Services related to the USA are shown below.
> Quality Assurance
FDA GMP / cGMP quality system implementation
Emergo Group has implemented FDA compliant GMP / cGMP quality systems for medical device companies throughout the USA and worldwide.
FDA GMP quality assurance outsourcing
We offer quality assurance outsourcing on a monthly, quarterly or “As Needed” schedule. We can assist you with GMP audits, document control and more.
GMP quality system and supplier audits
Our team of Certified Lead Assessors can audit your GMP (and/or ISO 13485) quality system, or conduct audits of your suppliers/subcontractors.
ISO 14971 risk management services
Let us help you adopt the ISO 14971:2007 risk management standard and integrate it with your existing quality system.
> Regulatory Affairs
FDA 510k Premarket Notification preparation and submission
Emergo Group can help you prepare and submit FDA 510(k) Premarket Notifications to the United States Food and Drug Administration (FDA).
FDA Form 483 and Warning Letter response and consulting
Has your medical device company received a FDA 483 and Warning Letter? We can help respond to the FDA and correct problems with your quality system.
FDA medical device classification determination
Not sure if your product is considered a “medical device” by the FDA? We will help you determine whether it is a medical device.
FDA Device & Establishment Registration
We can help you prepare and submit the FDA Device and Establishment Registration paperwork with the FDA.
US Agent representation
Emergo Group is a registered “United States Agent” with the FDA and represents more than 100 medical device and IVD companies worldwide.
FDA compliance regulatory outsourcing
Emergo Group offers FDA regulatory compliance outsourcing on a monthly, quarterly or “As Needed” schedule.
