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Resource Library for Medical Device Professionals

25 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
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
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
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
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
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
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
Download our white paper on EU Classification of Borderline and Combination Products
Europe

Classification Borderline: What Constitutes a Medical Device?

How do you classify a product that fits the definition of two or more product types? This paper explains borderline classification in the EU.

5 pages
Feb 25, 2016
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
Library card - Losing EU Notified Body White paper
Europe

Preparing to Change your European Notified Body

This white paper discusses how to find a new European Notified Body for MDR compliance.

9 pages
Jan 30, 2018
Download our whitepaper Introduction to CE Marking for Medical Devices in Europe
Europe

Introduction to CE Marking for Medical Devices

CE Marking is required to sell your medical device in Europe. Get an overview of the process, requirements, regulations, and more.

8 pages
Feb 11, 2013
Download our free white paper on ISO 10993-1 and Biocompatibility
Europe

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 free white paper on How to Select and Change a Notified Body in Europe
Europe

How to Select and Change a Notified Body in Europe

This white paper discusses key points of the Notified Body search, including how to find a new Notified Body well-suited to your company.

5 pages
Mar 13, 2014
Download our white paper on the role of Eudamed under the MDR/IVDR.
Europe | Medical Devices

The Role of Eudamed under the MDR and IVDR

In this white paper, you will learn about the role of Eudamed under the new MDR and IVDR.

14 pages
Jul 31, 2018
Download our free white paper on EU Medical Device Vigilance Reporting
Europe

EU Medical Device Vigilance Reporting

Vigilance reporting is confusing for many manufacturers in Europe but it is critical to comply with vigilance requirements. In this whitepaper, we'll answer your biggest questions about vigilance reporting.

7 pages
Jun 19, 2014
Download our white paper on EU medical device conformity assessments routes under the MDR.
Europe | Medical Devices

Conformity Assessment Routes under the EU Medical Devices Regulation (MDR 2017/745)

Download this white paper for an in-depth look at conformity assessment options under the new MDR.

9 pages
Aug 6, 2018
Download our free white paper on Clinical Investigation of Medical Devices
Europe

European Clinical Investigation of Medical Devices

How to avoid errors in communication, planning, conduct, evaluation, or reporting of clinical studies that could delay your market access in Europe.

10 pages
Jul 22, 2014
Download our white paper on Medical Device Labeling, Standards and Symbols
Europe

Medical Device Labeling, Standards and Symbols

Learn about the standards, requirements, and benefits of medical device labeling and symbols. Includes a list of common symbols and meanings.

7 pages
Sep 28, 2016
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
Download our white paper - Overview of ISO 11135:2014 and Medical Device Sterilization
Europe

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
Download our free white paper on Medical Device Clinical Evaluation Reports for CE Marking
Europe

Medical Device Clinical Evaluation Reports for CE Marking

The clinical evaluation report (CER) is a key component of Technical File and the CE Marking process so it's important to get it right.

5 pages
Jan 11, 2016
White paper: Medical device risk management landscape
Europe

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