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US FDA Consulting for Medical Device and IVD Manufacturers

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 demonstrate substantial equivalence for your medical device, implement a quality management system that complies with FDA Quality System Regulation (QSR), 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, device premarket clearance/approval, representation and quality system compliance.

FDA consulting services we offer:

  • FDA 510(k) Submissions for Obtaining FDA Clearance
  • FDA Investigational Device Exemption (IDE) submissions for US Clinical Studies
  • FDA Requests for Classification and Requests for Determination
  • FDA Pre-Submission Meetings
  • FDA QSR Consulting (21 CFR Part 820) for Medical Device and IVD Manufacturers
  • US 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 and their suppliers
  • FDA Form 483 Warning Letter Analysis, Response and Recovery
  • General Regulatory and Quality System Assistance and Training

Why choose Emergo as your FDA consulting firm?

  • We offer effective FDA regulatory support for all sizes of firms - from small, start-up medical device companies to large, multi-divisional corporations.
  • 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.

Contact us today for more information on our FDA consulting services.

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Frequently Asked Questions

Can registration certificates be transferred/ who owns the approval?

The person who submits the 510(k) is considered the owner of the FDA Clearance and remains so. The purchaser of a 510(k) notifies the FDA Document Control Center notifying of a new owner only. If the manufacturing site changes; a new 510(k) must be submitted and you must register with the FDA.

How long is my registration valid?

The regulatory clearance is valid until changes have occurred to the product. Changes need to be assessed to determine if the changes warrant a submission to the FDA.

What is considered a device family – what products can be in a single submission?

Devices that share the same FDA classification regulation/product code can often be “bundled” into a single submission.