Medical Device Consulting Services for the United States

Emergo Group helps medical device and IVD manufacturers with a variety of FDA medical device consulting issues. As specialized FDA consultants, we can assist you with many quality assurance, regulatory compliance and distribution management issues as shown below.

FDA 510(k) Clearance for Medical Devices

Emergo has assisted hundreds of companies in obtaining FDA clearance to sell their medical devices in the US.

FDA Quality System Regulation (QSR) Consulting

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 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 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 consultants can help you meet FDA validation requirements.