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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

85 total results. Use the filters to narrow down the results.
Australia

Medical Device Registration in Australia & New Zealand

This white paper answers your biggest questions about how to register your medical device or IVD in Australia or New Zealand.

Australia

Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.

Brazil

Brazil QMS Requirements For Medical Device Manufacturers

Thinking about selling your medical device in Brazil? This Brazillian market is complex but the sales potential is worth the effort.

Brazil

Medical Device Registration Process in Brazil

Interested in selling your medical device in Brazil? Brazil's device registration process is well established, but very complex. It's important to understand the process upfront to avoid delays down the road.

Brazil

Overview of the IVD Regulatory Landscape in Brazil

In this white paper, learn about recent changes to the regulatory process for IVDs in Brazil.

Brazil

Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.

Canada

Preparing a Canadian MDL Application

This white paper includes a detailed comparison of Health Canada's Medical Device License application and a US FDA 510(k).

Canada

Achieving QMS Compliance for Canada Beyond ISO 13485

An in-depth look at Quality Management System (QMS) regulations as they apply in Canada for obtaining a Medical Device License (MDL).

Canada

Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.

China | Medical Devices

China NMPA Medical Device Registration Requirements

This white paper discusses how to register your medical device in China.

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.

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.

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

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 | 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.

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?

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

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.

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.

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.

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.

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.

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.

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.

Europe | Medical Devices

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.

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

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.

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.

Europe

Preparing to Change your European Notified Body

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

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.

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.

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.