As the US Food and Drug Administration’s medical device and IVD review process becomes more complicated, partnering with an experienced FDA consultant can make a significant difference in your compliance efforts.
Whether your goal is to determine substantial equivalence for your medical device, implement a quality management system that complies with FDA Quality System Regulation, or obtain 510(k) premarket notification clearance, a skilled FDA consulting firm can assist you in your effort to meet all regulatory requirements.
Founded in 1997, Emergo has extensive experience providing FDA consulting to all sizes of medical device and IVD manufacturers seeking to bring their products to the US market. We have assisted medical device manufacturers worldwide with US FDA device classification, registration, representation and quality system compliance.
FDA consulting services we offer:
- FDA 510(k) Submissions for Obtaining FDA Clearance
- FDA QSR Consulting (21 CFR Part 820) for Medical Device and IVD Manufacturers
- US FDA Agent Representation for the FDA
- FDA QSR Training for Medical Device Companies
- FDA QSR Audits to QSR 21 CFR Part 820 for Medical Device Companies
- FDA Form 483 Warning Letter Analysis, Response and Recovery
Why choose Emergo as your FDA consulting firm?
- We specialize in FDA regulatory support for small- to medium-sized medical device companies.
- Our FDA consulting services are fully tailored to address your particular business needs.
- Our FDA consulting and project management teams coordinate efforts to deliver your services on time and within budget.
- We maintain constant accessibility and support both on- and off-site during the course of your FDA consulting project.