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Canadian flag
  • Regulatory Update
Jan 13, 2021

Canadian Regulatory Amendments Introduce Expanded Post-Market Surveillance Provisions

New amendments published by Health Canada impose stricter requirements for medical device manufacturers and greater powers for regulatory authorities relating to post-market surveillance and risk management.
European union flags flying in front of a gray building
  • Regulatory Update
Jan 13, 2021

European Commission Announces Appointments to Medical Device, IVD Expert Panels

European Commissioners have announced expert panelists for 12 high-risk medical device and IVD categories ahead of MDR, IVDR dates of application. Learn more at Emergo by UL.
Person using an at home blood pressure machine
  • Insights
Jan 13, 2021

Home Healthcare Products Take Center Stage

Increasing utilization of at-home healthcare delivery has implications for how manufacturers develop and design medical device user interfaces.
Drawing of a Wearable insulin pump
  • Insights
Jan 12, 2021

Design with the End User in Mind

Putting the user at the forefront of the medical device design process should start at the very beginning.
Open manhole with a gate around it
  • Insights
Jan 12, 2021

Mitigating the Risk Posed by Open and Obvious Hazards

"Open and obvious" use risks in medical products still warrant design efforts that mitigate these risks. Learn more about human factors engineering, design and usability issues at Emergo by UL.
View of London
  • Regulatory Update
Jan 5, 2021

UK MHRA Issues Post-Brexit Medical Device, IVD Registration Requirements

UK regulators clarify post-Brexit registration requirements and deadlines for medical devices, IVDs and related healthcare products. Learn more about UK medical device and IVD regulations at Emergo by UL.
Nurse filling a syringe
  • Regulatory Update
Dec 17, 2020

Cold Chain Management for COVID-19 Vaccines: Ensuring Safe and Effective Distribution

What pharmaceutical, medical device and other manufacturers should consider as vaccine cold chain processes evolve.
Surgeons operating on a patient
  • Insights
Dec 14, 2020

Choosing the Right Tissue Model for Medical Procedure Simulation

Selecting appropriate human body surrogates and substitute materials is important for accurate medical device, IVD and combination product usability testing and evaluation.
European Union flag
  • Regulatory Update
Dec 2, 2020

Eudamed Actor Module FAQ Now Live

The main reason for an economic operator to register in Eudamed has to do with the Single Registration Number (SRN).
Icon of the side of a person's head with gears turning inside their head
  • Insights
Dec 2, 2020

Important Considerations for Conducting In-Home Research

Human factors engineering for medical devices and IVDs is powered by user research, and some key usability results can be effectively obtained by meeting with users in their homes.
Doctors sitting at a table discussing notes
  • Insights
Nov 6, 2020

Six Everyday Products Initially Developed as Assistive Technology: Designing for Typically Excluded Users

In terms of medical device and IVD human factors engineering (HFE), usability and design, targeting "typically exclused" users can improve overall product benefit. Learn more at Emergo by UL's Human Factors Research & Design.
Person doing an audit.
  • Regulatory Update
Nov 4, 2020

MDSAP Council Updates Guidance on Conformity Assessments and Related Requirements

The participating regulators in the medical device single audit program (MDSAP) issued a new guidance documents that is consolidated from two existing documents and expanded with additional annexes.
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