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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

325 total results. Use the filters to narrow down the results.
Learn about the Egyptian regulations which apply to medical devices
Egypt

Egypt Medical Device Regulations

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

This chart illustrates CE Marking for medical devices under Europe's MDR.
Europe | Medical Devices

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.

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.

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.

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.

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.

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.

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.

Download the Chart on the IVD Approval Process in Europe
Europe | In-Vitro Diagnostic Devices

European IVD Regulatory Approval Process

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

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

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.

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?

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.

Conducting a medical device PMCF webinar
Europe | Medical Devices

WATCH NOW: Conducting a Medical Device PMCF Study

In this webinar, you'll learn what it takes to conduct a compliant Post-Market Clinical Follow-up study for your medical device.

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.

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.

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.

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.

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.

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.

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.

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?

Register for our webinar: Post Market Surveillance & PMCF under the European MDR
Europe

WATCH 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.

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.

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

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.

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.

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

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.

Europe

Belgium – Overview of medical device industry and healthcare statistics

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

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.

Europe

ASNM - French Agency for the Safety of Health Products

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

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.

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.

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.

Europe

Medical Device Consulting Services for Europe

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