{{ phone }} {{ location }}

Emergo by UL logo

     

Resource Library for Medical Device Professionals

47 total results. Show all resources.
This white paper discusses FDA guidance regarding wearable wellness products vs. medical devices.
United States | Digital Health Products, | Health and Wellness Products

Wearables vs. Regulated Medical Devices under the US FDA

In this white paper, we discuss how to determine if your wearable product is considered a regulated medical device by the US FDA.

7 pages
Jul 21, 2017
Our 510(k) calculator looks how long it has taken the FDA to clear specific devices during the past five years.
United States

How Long Will It Take My 510(k) to be Cleared by the FDA?

Use this calculator to see how many calendar days it usually takes the US FDA to clear medical devices with the same Product Code.

Interactive Calculator
Mar 19, 2014
Download our white paper on Understanding the US FDA UDI Regulation
United States

Understanding the US FDA UDI Regulation

Learn about the Unique Device Identification (UDI) regulation, how to obtain a UDI number, compliance deadlines, and more.

5 pages
Jun 10, 2014
Register for our webinar: Mapping UL 2900 Cybersecurity Standards to FDA Guidance
United States | Digital Health Products

WATCH NOW: Mapping cybersecurity standards to FDA guidance

A set of standards published by UL to address medical device cybersecurity issues will soon be adopted. In this one hour webinar, we discuss various aspects of medical device cybersecurity and how the new UL 2900 standards map to FDA guidance.

1 hour
Jul 12, 2017
Learn about the US FDA regulations which apply to medical devices
United States

USA Medical Device Regulations

A comprehensive list of medical device regulations in United States with links to the original documents.

Downloadable PDFs
Jan 1, 2015
Download our white paper on Preparing a US FDA Medical Device 510(k) submission
United States

Preparing a US FDA Medical Device 510(k) Submission

US FDA 510(k)s have unique content and format requirements. Get an overview of preparing and submitting a 510(k).

10 pages
Mar 30, 2016
Download the Chart on the Medical Device Approval Process in the USA
United States

US FDA Registration Process for Medical Devices

This chart illustrates the steps in the US FDA's medical device approval process and includes a timeline of expected approval.

2 pages
Jan 1, 2015
US FDA 510(k) process video
United States

In Depth: The US FDA 510(k) Clearance Process

In this 8-minute video, we discuss the steps you should take to prepare and submit a 510(k) to the US FDA.

8 minutes
Apr 23, 2018
United States

In Depth: US FDA Medical Device Registration and Compliance

This video series about the United States' medical device market shows you the process and identifies the key concepts to know before you begin.

24 minutes
Jan 25, 2012
Download our white paper on Understanding the US FDA Device Classification System
United States

Understanding the US FDA Device Classification System

Correct classification of a medical device is critical for identifying its proper regulatory route in the United States.

13 pages
Feb 9, 2015
WATCH NOW: Overview of the MDSAP Certification Process
United States | Medical Devices

WATCH NOW: Overview of the MDSAP Certification Process

In this one-hour webinar, you will learn what it takes to obtain MDSAP certification from two of Emergo's QMS consultants.

1 hour
Aug 1, 2018
Watch this Short Video: Introduction to the United States FDA's medical device approval process
United States

Introduction to US FDA Medical Device Regulatory Process

This video about the United States medical device market gives an overview of the regulatory framework and registration process basics.

4 minutes
Sep 21, 2015
United States

Introduction to the UDI System in the USA

This video describes key aspects of the FDA UDI system, why it is necessary, benefits, and when and how device manufacturers need to comply.

5 min
Nov 23, 2015
Download our white paper - Introduction to FDA QSR Compliance for Startup Medical Device Companies
United States

Introduction to FDA QSR Compliance for Startup Medical Device Companies

This white paper provides a high-level overview of the US FDA 21 CFR Part 820 and the implementation process, including timelines and strategies.

8 pages
Aug 16, 2016
Download our white paper on FDA Regulation of Medical Products Containing Human Cells or Tissues
United States

US FDA Regulation of Human Cell and Tissue Products

Does your medical device contain animal or human cells or tissues? Learn about FDA requirements for these products.

6 pages
Apr 15, 2014
Download our white paper - Guide to US FDA Regulations for Novel and Innovative Products
United States

US FDA Regulations for Novel and Innovative Products

This whitepaper discusses how to bring a novel device to the US market, including common pathways, exemptions, and the de novo process.

8 pages
Aug 22, 2016
United States

Overview of the USA FDA Classification Process

This short video covers FDA classification, how to use the classification database, and useful tips for classifying your medical device.

7 min
Jan 12, 2016
Download white paper - What to Expect During USA QSR Inspections
United States

What to Expect During an FDA QSR Inspection

This paper describes exactly what to expect from a random FDA audit and how to prepare for the inspector's arrival in a concise checklist.

9 pages
Aug 25, 2016
Download our white paper on Early Communication with the FDA
United States

Early Communication with the FDA

Discover guidelines, tips, and other useful information about corresponding with the FDA about the clearance of your medical device.

6 pages
Dec 5, 2014
Download our white paper on mplementing a Medical Device Post-Market Surveillance Program
United States

Implementing a Medical Device Post-Market Surveillance Program

Post-market surveillance is a regulatory requirement the US and Europe and helps you ensure your device's safety and effectiveness.

6 pages
Mar 14, 2016
Download our free white paper on Does Your Mobile App Need FDA clearance?
United States | Digital Health Products, | Health and Wellness Products

Does Your Mobile App Need FDA Clearance?

Are you ready to launch your mobile medical app in the United States? Depending on the functionality of your app, you might need clearance from the US FDA.

7 pages
Apr 21, 2016
United States

Medical Device Consulting Services for the USA

Interested in selling your medical device or IVD in the United States? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.

Varies
May 19, 2008
Download our white paper on Regulations for Companion Diagnostics in the US and EU
United States

Regulations for Companion Diagnostics in the US and EU

In this paper, we answer your biggest questions about the obstacles and opportunities of marketing companion diagnostics in the US and Europe.

5 pages
Nov 11, 2016
Download our white paper on Usability Studies and the US FDA
United States

Usability Studies and the US FDA

Learn about usability engineering studies, including FDA requirements, standards, and how to conduct a usability study.

7 pages
Jan 2, 2015
United States

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

7 min
Nov 22, 2016
United States

In Depth: 21 CFR Part 820 - FDA Quality System Regulation

In this video, we’ll take a look at 21 CFR Part 820, including an overview, key players, important sections, and how to maintain compliance.

11 min
May 18, 2016
Download our white paper: Medical Device Testing Requirements for 510(k) Submissions
United States

Medical Device Testing Requirements for 510(k) Submissions

In a 510(k) submission, what testing is required by the FDA to clear the device? While testing requirements are easy to determine for some devices, other devices require intensive research.

24 pages
Jan 9, 2017
Download our Whitepaper - Cybersecurity and the US FDA
United States | Digital Health Products

US FDA Cybersecurity Requirements for Medical Devices

In this white paper, we discuss US regulations for wireless medical devices, including submission requirements, risk management, and more.

6 pages
May 24, 2016
Download our free white paper on US FDA 510(k) Requirements for Devices Labeled Sterile
United States

FDA 510(k) Requirements for Devices Labeled Sterile

When preparing a 510(k) submission for a device labeled as sterile, you should carefully consider which sterilization method to use because it will affect the FDA’s expectation.

7 pages
Feb 13, 2017
Download our white paper on Determining Substantial Equivalence for FDA Device Clearance
United States

Determining Substantial Equivalence for FDA Device Clearance

Learn about substantial equivalence, which is the key to getting your Class II medical device cleared for sale by the US FDA.

7 pages
Jun 15, 2016
Fill out our short form to request information about the USA
United States

Get smart about the USA in 1 hour

Thinking about entering the US market for the first time? Understanding the FDA regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter the US market.

1 page
May 1, 2017
United States

How to Prepare for an FDA Inspection

In this video, we discuss what medical device companies should do (and what not to do) before, during, and after a random FDA audit.

4 minutes
Aug 9, 2016
Register for our webinar: Getting 510(k) Clearance for Your Device from the US FDA
United States

WATCH NOW: Getting 510(k) Device Clearance from the US FDA

The US is the largest medical device market in the world but gaining regulatory approval from the FDA is not fast, cheap or easy. In this one hour webinar, we demystify the process and explain what you need to do before starting your 510(k) submission.

1 hour recording
May 22, 2017
Download our white paper about global compliance for medical devices.
United States

Global Compliance Strategy for Medical Devices

This white paper discusses potential strategies for achieving global market compliance for your device.

10 pages
Jun 22, 2017