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Korean building at night
  • Regulatory Update
2023年12月8日

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 Mexican flag waving at Zócalo in Mexico City
  • Insights
2023年12月7日

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...
European Union flag flying in the wind
  • Regulatory Update
2023年11月15日

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...
Man planning medical device UI design
  • Insights
2023年11月9日

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...
Graph showing how human factors are affected by AI
  • Insights
2023年11月8日

AI's Role in Enhancing Accessibility in Healthcare

Here we discuss how artificial intelligence empowers accessibility.
View of Brazil at night
  • Regulatory Update
2023年11月8日

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...
Boy checking smart thermostat.
  • Insights
2023年11月8日

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...
Aeriel view of Rio de Janeiro
  • Regulatory Update
2023年11月7日

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...
Man using lighted touchscreen on smartphone
  • Insights
2023年11月7日

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...
People on usability testing panel
  • Insights
2023年11月7日

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...
Globe with push pins indicating certain countries.
  • Insights
2023年10月24日

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...
Unique Device Identifier (UDI) label
  • Regulatory Update
2023年10月23日

EC adopts exceptions to contact lenses and UDI-DI assignment

The European Medical Devices Regulation (Regulation 2017/745, MDR) requires each specific model of a device to have its...
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