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Resource Library for Medical Device Professionals

24 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
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 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
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
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 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: 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 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
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 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 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 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
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 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 - 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
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
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 free white paper on ISO 10993-1 and Biocompatibility
United States

ISO 10993-1 and Biocompatibility for Medical Devices

If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements.

16 pages
Apr 22, 2016
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
White paper - MDSAP certification
United States

Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.

8 pages
Jan 15, 2018
Download our white paper about Clinical Data in support of FDA 510(k) submissions
United States

Clinical Data in Support of US FDA 510(k) Submissions

This white paper US quality assurance requirements for human clinical studies and breaks down the key elements compliant study.

5 pages
Sep 16, 2016
Download our free white paper on Managing Medical Device Supplier and Purchasing Controls
United States | In-Vitro Diagnostic Devices, | Medical Devices

Managing Medical Device Supplier and Purchasing Controls

This white paper addresses Purchasing Controls, one of the biggest QSR compliance vulnerabilities for medical device companies selling in the US.

9 pages
Feb 23, 2015
Download our white paper - Overview of ISO 11135:2014 and Medical Device Sterilization
United States

Overview of ISO 11135:2014 and Medical Device Sterilization

ISO 11135:2014 is recognized as the international standard for process management and validation requirements of Ethylene Oxide (EO) sterilization.

12 pages
Sep 29, 2016
White paper: Medical device risk management landscape
United States

Medical Device Risk Management in the New Regulatory Environment

Regulatory expectations for risk management are increasing - what does this mean for medical device companies?

9 pages
May 30, 2018