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EU flag waving in front of a building
  • Insights
Dec 11, 2023

EU Compliance, Strategies and Goals for MDR and IVDR

Emergo by UL professionals gave an update on EU Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostic Devices Regulation (IVDR, 2017/746) compliance.
Korean building at night
  • Regulatory Update
Dec 8, 2023

South Korea Update: Release of IVD Clinical Performance Testing Institutions and More

South Korea’s regulator MFDS announced several regulatory changes that medical device manufacturers who do business in the country should review.

The Mexican flag waving at Zócalo in Mexico City
  • Insights
Dec 7, 2023

Towards Global Medical Device Regulatory Alignment: Changes in Latin American Markets

Regulators in Brazil, Mexico and other Latin American medical device markets move toward harmonization with other regions
European Union flag flying in the wind
  • Regulatory Update
Nov 15, 2023

European Notified Body Survey Shows Uptick in MDR, IVDR Applications

Data from the European Commission shows increase in Notified Body activities around MDR, IVDR applications and certifications through June 2023
Man planning medical device UI design
  • Insights
Nov 9, 2023

UI Design in 5 to 9

Designers can use the principles of working memory as an aid to developing UI’s that are intuitive and not overwhelming to users.
Graph showing how human factors are affected by AI
  • Insights
Nov 8, 2023

AI's Role in Enhancing Accessibility in Healthcare

Here we discuss how artificial intelligence empowers accessibility.
View of Brazil at night
  • Regulatory Update
Nov 8, 2023

Update: Brazil Registrations and Foreign Medical Device Regulators

RDC 741/2022 was released in August 2022 to acknowledge that the regulator in Brazil, ANVISA, would leverage registrations from foreign regulatory agencies for identical devices.

Boy checking smart thermostat.
  • Insights
Nov 8, 2023

Wiklund’s Perspective on Product Capabilities, Complexity and Intuitiveness

My caution to product developers is to know your target customer, the degree of product sophistication consumers say they want versus will use, and to build as much intuitiveness as possible into every product.
Aeriel view of Rio de Janeiro
  • Regulatory Update
Nov 7, 2023

Consultation to Extend Brazil GMP Certificate Validity for MDSAP Submissions

Medical devices marketed in Brazil must be made by a manufacturer who is QMS compliant with the Brazil Good Manufacturing Practice (RDC 665/2022 and RDC 497/2021).

Man using lighted touchscreen on smartphone
  • Insights
Nov 7, 2023

Dark Mode vs Light Mode for Medical Device UIs

User interface design plays a crucial role in product user experience and is important when used to convey critical information in medical devices. A recent ongoing debate is light vs dark modes.

People on usability testing panel
  • Insights
Nov 7, 2023

Leading and Moderating Medical Usability Tests

Here is an overview of learnings we shared during our recent webinar on leading usability test sessions. It discusses the importance of asking great questions.
Globe with push pins indicating certain countries.
  • Insights
Oct 24, 2023

RAPS Convergence 2023: Until We Meet Again Next Year

Since RAPS Convergence 2023 concluded, we're still celebrating its success. The exhibit halls percolated with the fervor of discussions.

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