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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

329 total results. Use the filters to narrow down the results.
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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Download our white paper on Usability Studies and the US FDA
United States | Combination Products

Usability Studies and the US FDA

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

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.

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.

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.

Compare the time, cost and complexity of getting regulatory approval for medical devices
United States

Time, Cost and Complexity of Regulatory Approvals Worldwide

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.

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.

Learn about basic demographic and healthcare market data on the United States
United States

USA – Overview of medical device industry and healthcare statistics

A brief look at the United States' medical device market, including potential opportunities and obstacles for manufacturers.

How long does it take the FDA to clear 510(k) submissions? We look at 5 years of data to identify trends.
United States

How long it takes the US FDA to approve 510(k) submissions

How long does it take the FDA to clear 510(k) submissions? We look at 5 years of data to identify trends.

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.

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.

Libary card - US FDA de novo webinar - May 2018
United States

WATCH NOW: Understanding the US FDA De Novo Process for Novel Medical Devices

In this one-hour webinar, we discuss the benefits and criteria of the FDA de novo process for novel medical devices.

United States

FDA - US Food and Drug Administration

Learn about the regulatory structure in the United States and major medical device regulations.

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.

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?

United States

What is a 510(k)?

Learn about the FDA 510(k) process in this informative page from Emergo


How ISO 13485:2016 Impacts Medical Device Companies

ISO 13485:2016 provides an international QMS standard and introduces notable changes, particularly in the area of risk management.

2018 Medical Device Industry Outlook Survey

2018 Outlook for the Medical Device Industry

The 2018 Global Medical Device Industry Outlook contains unique insights and expectations for the coming year from industry professionals around the world.

Register for our free webinar on Transitioning to ISO 13485:2016

WATCH NOW - What You Need To Know about ISO 13485:2016

In this recorded webinar we cover the major changes that have been made and tell you what needs to be done before you seek recertification by your Notified Body.


WATCH NOW: Human Factors Engineering for Medical Devices

This webinar will help guide you toward a better HFE approach to medical device design and development.

Worldwide | Medical Devices


Learn how RAMS-Track can help you avoid costly expirations, save time, and stay informed about regulatory changes.