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Resource Library for Medical Device Professionals

67 total results. Show all resources.
Download our white paper: How ISO 13485:2016 Impacts Medical Device Companies
Europe

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.

16 pages
Feb 1, 2016
Download our white paper on Understanding Europe's New In Vitro Diagnostic Medical Devices Regulation
Europe

Understanding Europe's New IVDR 2017/746

Europe's new IVDR 2017/746 will bring significant regulatory changes for IVD manufacturers selling in Europe.

16 pages
Oct 31, 2016
This chart illustrates CE Marking for medical devices under Europe's MDR.
Europe

Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process

This chart illustrates steps to CE Marking in Europe's Medical Devices Regulation (MDR 2017/745) approval process.

2 pages
Aug 23, 2017
Emergo MDR webinar October 2017
Europe

WATCH NOW: The new European Medical Devices Regulation (MDR 2017/745)

In this webinar, we outline the most important MDR changes you need to know.

1 hour
Sep 15, 2017
Register for our free webinar on Transitioning to ISO 13485:2016
Europe

WATCH IT 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.

1 hour
Dec 15, 2016
Register for our free webinar on choosing or changing your EU Notified Body
Europe

WATCH NOW: How to Select or Change Your EU Notified Body

In this recorded webinar we will tell you how to deal with the issue of transitioning to another Notified Body and/or how to evaluate your options in establishing a new relationship.

1 hour
Jan 4, 2017
Download our white paper on Understanding Europe's New Medical Device Regulation
Europe | Medical Devices

Understanding Europe's New Medical Device Regulation - MDR 2017/745

Europe's new Medical Device Regulation 2017/745 (MDR) will bring substantial changes to the medical device industry. How will this affect your company?

28 pages
Jul 5, 2016
Register: Eudamed Webinar July 2018
Europe | In-Vitro Diagnostic Devices, | Medical Devices

WATCH NOW: Eudamed Requirements under the EU MDR and IVDR

In this one-hour webinar, Ronald Boumans discusses the role of Eudamed in MDR/IVDR compliance.

1 hour
Jun 12, 2018
Download the Chart on the Medical Device Approval Process in Europe
Europe | Medical Devices

Europe CE Marking Regulatory Process for Medical Devices

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

2 pages
Aug 29, 2013
Download the Chart on the IVD Approval Process in Europe
Europe

European IVD Regulatory Approval Process

This chart illustrates the steps in Europe's IVD approval process and includes a timeline of expected approval.

2 pages
Aug 29, 2013
Watch this Short Video: Introduction to Europe's CER
Europe

Introduction to Clinical Evaluation Reports (CER) for Europe

This video explores CERs, including what they are, why you need one, the research process, and contents and formatting.

4 minutes
Mar 15, 2016
Europe

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
ISO 13485 2016 risk based approach white paper
Europe

ISO 13485:2016 and the new Risk-based Approach

This white paper provides an overview of new risk requirements and considerations for devices companies under the new standard.

12 pages
Sep 6, 2017
Download our white paper on CE Marking Conformity Assessment for Medical Devices
Europe

CE Marking Conformity Assessment for Medical Devices

Your conformity assessment route has implications for your business you might not expect. How do you know which route is best for you?

6 pages
Mar 29, 2016
Learn about the European Directives and Regulations which apply to medical devices
Europe

Medical Device Regulations in Europe

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

Downloadable PDFs
Jan 1, 2015
Whatch this Short Video: Introduction to ISO 13485 in the EU
Europe

Introduction to ISO 13485 compliance for Europe

In this video, learn more about the background of EN ISO 13485, and the steps you can take to obtain ISO 13485 certification in Europe.

29 minutes
Nov 9, 2015
Download our white paper on ISO 14971 Medical Device and IVD Risk/Benefit Analysis
Europe | Medical Devices

ISO 14971 Medical Device and IVD Risk/Benefit Analysis

This white paper explores risk management procedures and protocols required to comply with ISO 14971.

9 pages
Jun 17, 2016
Register for our webinar: Post Market Surveillance & PMCF under the European MDR
Europe

WATCH IT NOW: PMS & PMCF under the European MDR

Europe's new Medical Devices Regulation (MDR) adds to the complexity of complying with specific PMS and post-market clinical follow-up (PMCF) requirements. In this free webinar, we discuss new European PMS and PMCF requirements.

1 hour live webinar
Apr 10, 2017
Watch this Short Video: Introduction to Europe's medical device approval process
Europe

Introduction to European CE Marking for medical devices

This video about provides an overview of the regulatory framework and registration process basics for devices.

4 minutes
Sep 21, 2011
Download our white paper on Preparing a European CE Technical File for a Medical Device
Europe

Preparing a European CE Technical File for a Medical Device

Take a deep dive into the key elements of an EU Technical File, including preparation, formatting, and common elements.

8 pages
Nov 24, 2015
This short video describes the six biggest changes in ISO 13485:2016.
Europe

ISO 13485:2016: Six Key Differences for Medical Device Companies

This short video covers the 6 biggest changes in the new ISO 13485:2016.

5 minutes
Jun 27, 2017
14971 risk management webinar
Europe | Medical Devices

WATCH NOW: Risk Management according to EN ISO 14971:2012

This free recorded webinar is about risk management for medical device companies according to EN ISO 14971:2012.

One hour
Aug 10, 2017
Download our white paper on Regulations for Companion Diagnostics in the US and EU
Europe

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 mplementing a Medical Device Post-Market Surveillance Program
Europe

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
Watch our recent webinar on the European In Vitro Diagnostic Devices Regulation
Europe

WATCH NOW: Europe's New IVDR 2017/746

Within the next few years, the regulatory landscape will change dramatically for IVD companies selling in Europe. IVDR 2017/745 will be an entirely new classification scheme for IVDS, and places far more emphasis on clinical data and risk management

1 hour
Nov 18, 2016
Europe

UK – Overview of medical device industry and healthcare statistics

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

1 web page
Aug 28, 2014
Europe

MHRA - UK Medicines and Healthcare Products Regulatory Agency

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

1 page
Feb 11, 2014
EU PMCF studies white paper
Europe

Post-Market Clinical Follow-up (PMCF) Studies in Europe

This white paper discusses PMCF study requirements in Europe and relevant changes under the new MDR.

7 pages
Sep 6, 2017
Europe

Czech Republic – Overview of device industry and healthcare statistics

A brief look at the Czech Republic's medical device market, including potential opportunities and obstacles for manufacturers.

1 web page
Aug 28, 2014
Download our free white paper on Unannounced Audits and your Critical Suppliers
Europe | In-Vitro Diagnostic Devices, | Medical Devices

Unannounced Notified Body Audits & Your Critical Suppliers

In this white paper, we discuss audit and assessment duties for Notified Bodies in Europe, including performing unannounced audits.

9 pages
Nov 12, 2014
Europe

ASNM - French Agency for the Safety of Health Products

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

1 page
Feb 11, 2014
Europe

FRANCE – Overview of medical device industry and healthcare statistics

A brief look at France's medical device market, including potential opportunities and obstacles for manufacturers.

1 web page
Aug 28, 2014
Download our white paper on Clinical Investigational Studies for Medical Devices in Europe
Europe

Clinical Investigational Studies in Europe

This white paper discusses the European clinical investigation requirements and how to know when you're ready for this important step.

5 pages
Dec 12, 2016
Europe

AEMPS - Spanish Agency of Medicine and Sanitary Products

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

1 page
Feb 11, 2014