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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

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

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

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


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.


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.


Global Translation Requirements for Medical Devices

This white paper discusses requirements and best practices for translating device labeling and Instructions for Use (IFU).

Register for our free webinar on Risk Management changes in ISO 13485:2016

WATCH NOW - Risk Management Changes in ISO 13485:2016

In this recorded webinar, we discuss how risk management requirements for medical device manufacturers will expand significantly with the publication of ISO 13485:2016. Manufacturers will have to change how they integrate it with their quality systems.

Worldwide | Digital Health Products

Overcoming Common Compliance Issues for Medical Software

It's not always clear what regulations apply to software. Regulatory authorities across the globe have provided little (or confusing( guidance, leaving developers to question: When is software considered a medical device?


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.


WATCH NOW: Sterile Medical Device Packaging Requirements to EN ISO 11607

In this free webinar, we will outline how to comply with sterile medical device package testing requirements in EN ISO 11607.

Read our survye on the impact of currency changes on medical device sales and profitability

Impact of Currency Changes on Medical Device Sales and Profitability

Emergo conducted a survey on the impact of currency changes (increase/decrease of the US Dollar) on medical device sales and profitability worldwide.


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.

Review our list of medical device industry terms

Glossary of Medical Device Industry Terms

What is a 510(k)? Or ISO 13485? or a form 483? ANVISA, AIMDD, Compentent Authority ... all these industry terms and more are available in this quick glossary.


Sample Medical Device Regulatory Compliance Page for your Website

Having a dedicated regulatory compliance page is useful to prospective customers, end users, distributors and regulatory officials. This sample page shows how you could display your company's compliance details.

webinar - risk management landscape April 2018

WATCH NOW: Risk Management for Medical Devices in the New Regulatory Environment

In this webinar, we will discuss how regulatory expectations for risk management are changing for medical device manufacturers.

Download the free chart on Worldwide Spending on Healthcare

Worldwide Spending on Healthcare

This table gives you an idea of how much money is spent on healthcare in various countries worldwide, and who pays for it.

Download our white paper about global compliance for medical devices.

Global Compliance Strategy for Medical Devices

This white paper discusses potential strategies for achieving global market compliance for your device.


Overview of regulations for 3D printed medical devices

This white paper discusses regulatory considerations for 3D printed medical devices in various markets.

Download the Results of 2017 medical device industry survey

2017 Outlook for the Medical Device Industry

The Global Medical Device Industry Outlook contains unique insights and expectations for the coming year from industry professionals around the world.

Worldwide | 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.


Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

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

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

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.


Medical Device Risk Management in the New Regulatory Environment

Regulatory expectations for risk management are increasing - what does this mean for medical device companies?