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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

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

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.

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.

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

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.

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

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.

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

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.

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

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

Early Communication with the FDA

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

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.

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.

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

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.

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 | 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.

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.

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.

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.

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.

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

Worldwide

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.

Worldwide | Medical Devices

EXPLORE RAMS-TRACK

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

Emergo webinar - wireless device requirements 2019
Register for our free webinar on Transitioning to ISO 13485:2016
Worldwide

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.

Learn about RAMS-Track in this case study.
Worldwide | Medical Devices

Case Study: Simplify Device Registration Tracking with RAMS-Track

In this case study, learn how three device companies used RAMS-Track to simplify RA activities.