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TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.

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619 results
Aeriel view of Rio de Janeiro
  • Regulatory Update
2021年1月18日

New Brazil INMETRO Ordinance Eases Inspection and Documentation Requirements

In Brazil, a new ordinance was published by the National Institute of Metrology, Standardization and Industrial Quality...
Binary numbers as a planet in space
  • Regulatory Update
2021年1月15日

US FDA Unveils Next Steps for Regulating Artificial Intelligence-Based Medical Software

US regulators explain evolving approach to oversight of SaMD based on artificial intelligence and machine learning....
Canadian flag
  • Regulatory Update
2021年1月13日

Canadian Regulatory Amendments Introduce Expanded Post-Market Surveillance Provisions

New amendments published by Health Canada impose stricter requirements for medical device manufacturers and greater...
European union flags flying in front of a gray building
  • Regulatory Update
2021年1月13日

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,...
Person using an at home blood pressure machine
  • Insights
2021年1月13日

Home Healthcare Products Take Center Stage

Increasing utilization of at-home healthcare delivery has implications for how manufacturers develop and design medical...
Drawing of a Wearable insulin pump
  • Insights
2021年1月12日

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
2021年1月12日

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...
View of London
  • Regulatory Update
2021年1月5日

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...
Nurse filling a syringe
  • Regulatory Update
2020年12月17日

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
2020年12月14日

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...
European Union flag
  • Regulatory Update
2020年12月2日

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
2020年12月2日

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...
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