Medical Device Consulting Services for the United States
Emergo Group helps medical device and IVD manufacturers with a variety of FDA regulatory consulting issues. As specialized FDA consultants, we can assist you with many quality assurance, US regulatory compliance and distribution management issues as shown below.
FDA 510(k) Clearance for Medical Devices
Emergo has helped hundreds of companies obtain FDA regulatory clearance to sell their medical devices in the US.
FDA GMP Consultants (Good Manufacturing Practice)
Our FDA consultants implement quality systems that meet the Quality System Regulation (QSR) requirements.
US FDA Agent Representation
Emergo acts as the official US Agent representative for more than 100 device companies worldwide.
US Medical Distributor Search
There are thousands of US medical distributors. We will find and qualify those best suited to your needs.
FDA GMP (QSR) Training
On-site training especially designed for employees that are new to FDA Quality System Regulation.
FDA GMP (21 CFR Part 820) Quality System Audits
Our certified auditors will ensure that your company (or key supplier) is meeting FDA QSR requirements.
QA & RA Due Diligence Audits
Merger? Acquisition? Let us ascertain the company's level of compliance with US and other regulations.
FDA Form 483 or Warning Letter Response
We can assist in correcting problems with your FDA quality system as noted by an FDA inspector.
FDA Investigational Device Exemption (IDE) Consulting
Our FDA consulting team can help you obtain an Investigational Device Exemption from the FDA.
FDA 513(g) Consulting for Medical Devices
If the classification of your device is unclear, we can assist in obtaining an official ruling from the FDA.
ISO 14971:2007 Risk Management
We have integrated the ISO 14971 standard into many GMP and ISO quality management systems.
Validation Consulting for Products, Processes, Equipment and Software
Our FDA consultant can help you meet FDA validation requirements.
Click on the image to download this PDF of the medical device approval process in the USA
