Emergo by UL resources

Medical professional using electronic controls to test a medical scanning device.

Design and Evaluation of Electronic Instructions for Use (eIFUs)

Join the HFE experts at Emergo by UL as they discuss regulator expectations for electronic instructions for use (eIFUs).

Technician operating diagnostic equipment for a patient.

New Medical Device Usability Engineering Standard from MHLW

The new JIS T62366-1:2022 standard comes with updated requirements on usability engineering for medical devices.

2022 Outlook – Updates for Europe’s Regulatory Landscape: Recent Changes in the EU, United Kingdom and Switzerland

Watch this webinar to learn the anticipated updates to the EU IVDR 2017/746 and EU MDR 2017/745, what to look out for from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the next steps for Switzerland.

2022 Outlook and Updates for the US Food and Drug Administration

Review recently released and expected guidance documents from the US FDA, the growing use of real-world evidence and regulatory science tools in submissions, and expectations for 2022 and beyond.

Performance Evaluation – When, What and How to Prepare for EU IVDR

This webinar explains the Performance Evaluation concept introduced by IVDR 2017/746 and focuses on the interaction of elements required for manufacturers to perform an adequate Performance Evaluation.

MDR Update: Common Themes from Medical Device Manufacturers

In this complimentary webinar, we examine resources developed by the European Commission.

Phone with app being used for blood glucose monitoring.

Software as a Medical Device (SaMD): EU/US Regulatory Considerations

In this webinar, we provide information on considerations for designing and classifying SaMD in the United States and European Union.

Office supplies over drawing of risk mapping.

Scaling and Conducting Use-Related Risk Analysis (URRA)

Watch the HFE experts at Emergo by UL as they discuss the importance of conducting URRAs effectively.

Senior man using blood pressure cuff in his home

Bringing Medical Devices Home

Watch as HFE experts discuss the application of HF engineering to medical devices intended for at-home use.

Medical Device Registration – Brazil ANVISA

In this complimentary webinar, we examine current medical device registration requirements in Brazil, recent regulatory changes and current ANVISA registration requirements.

6 Key Principles of GDPR

General principles of GDPR and actions manufacturers can take to gain or maintain compliance.

HIPAA Regulations

Secure data management to meet HIPAA, PHI, and requirements of Covered Entities or Business Associates.

HIPAA & GDPR Overview

Secure data management to meet HIPAA, GDPR requirements and achieve regulatory compliance.

EU MDR Readiness Assessment Checklist

Use this short checklist to assess what your medical device company needs to do to comply with the EU MDR.

Taiwan TFDA Regulatory Approval Process for Medical Devices & IVDs

All manufacturers planning to sell a medical device in the Taiwan need to register their product with the Taiwan Food and Drug Administration (TFDA).

India Approval Process for Medical Devices & IVDs

Before manufacturers of certain medical devices can sell within India, they need to be in compliance with India’s medical device regulations.

European IVD Regulatory Approval Process

All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.

Europe In Vitro Diagnostic Devices Regulation (IVDR) CE Marking Regulatory Process

This certification verifies that a device meets all regulatory requirements for IVDs, which will soon change under the new in vitro diagnostic regulation (IVDR 2017/746).

Bangladesh Medical Device & IVD Approval Process

Our Bangladesh regulatory process chart offer intuitive, high-level overviews of your path to product registration.

US FDA Registration Process for Medical Devices and IVDs

All companies planning to sell a medical device or IVD in the United States need to register their product with the US FDA.

We have deep expertise with a range of product types, including combination and borderline products.

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All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS).
Get your first chart for free when you create a RAMS account.