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Resource Library for Medical Device Professionals

Resource Library for Medical Device Professionals

24 total results. Use the filters to narrow down the results.
Brazil registration webinar 2018
Brazil

WATCH NOW: Brazil ANVISA Medical Device Registration

In this free webinar, we discuss how to register your medical device with ANVISA and recent regulatory changes in Brazil.

WATCH NOW: Overview of the MDSAP Certification Process
Canada | Medical Devices

WATCH NOW: Overview of the MDSAP Certification Process

In this one-hour webinar, you will learn what it takes to obtain MDSAP certification from two of Emergo's QMS consultants.

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.

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.

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

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.

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.

CER Complience webinar EMERGO 2018
Europe

WATCH NOW: Ensure Your CER Complies with MEDDEV 2.7/1 v4

In this webinar, we outline what you need to know about writing a compliant EU Clinical Evaluation Report.

India | Combination Products

WATCH NOW: Human Factors Engineering for Combination Products

In this one-hour webinar, we discuss HFE requirements for combination products.

Watch our recent webinar on Medical Device Approval in Japan
Japan

WATCH NOW: Japan's Medical Device Approval Process

Learn about the most complex aspects of the Japanese medical device registration process from EMERGO's VP of Business Development.

Mexico | Medical Devices

WATCH NOW: Medical Device Registration in Mexico

In this one-hour recorded webinar, you will learn what it takes to register a medical device with COFEPRIS in Mexico.

Register for our webinar: Mapping UL 2900 Cybersecurity Standards to FDA Guidance
United States | Digital Health Products

WATCH NOW: Mapping cybersecurity standards to FDA guidance

A set of standards published by UL to address medical device cybersecurity issues will soon be adopted. In this one hour webinar, we discuss various aspects of medical device cybersecurity and how the new UL 2900 standards map to FDA guidance.

Register for our webinar: Getting 510(k) Clearance for Your Device from the US FDA
United States

WATCH NOW: Getting 510(k) Device Clearance from the US FDA

The US is the largest medical device market in the world but gaining regulatory approval from the FDA is not fast, cheap or easy. In this one hour webinar, we demystify the process and explain what you need to do before starting your 510(k) submission.

Libary card - US FDA de novo webinar - May 2018
United States

WATCH NOW: Understanding the US FDA De Novo Process for Novel Medical Devices

In this one-hour webinar, we discuss the benefits and criteria of the FDA de novo process for novel medical devices.

Worldwide | Medical Devices

EXPLORE RAMS-TRACK

Learn how RAMS-Track can help you avoid costly expirations, save time, and stay informed about regulatory changes.

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

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.

Worldwide

WATCH NOW: Human Factors Engineering for Medical Devices

This webinar will help guide you toward a better HFE approach to medical device design and development.

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

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

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.

webinar - risk management landscape April 2018
Worldwide

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.