News

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

Nov 9, 2023

Design Medical Device UIs in 5-9 for Human Working Memory

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

Nov 8, 2023

AI and Accessibility

Here we discuss how artificial intelligence empowers accessibility.

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.

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.

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

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.

Nov 7, 2023

How to Lead and Moderate a Usability Test

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.

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.

Oct 23, 2023

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 own unique UDI-DI. Since contact lenses come in a broad variety, this would require manufacturers to assign a great number of UDI-DIs.

Oct 20, 2023

New European Guidance Clarifies Medical Device Software Requirements

The EC and MDCG address medical device software compatible with or embedded in hardware devices (such as smartphones, smartwatches, or apps) and software.

Oct 20, 2023

Thailand FDA and Singapore HSA Regulatory Reliance Program

The Thai FDA has recognized the Singapore Health Sciences Authority as a reference regulatory agency to expedite registration of medical devices.

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European Notified Body Survey Shows Uptick in MDR, IVDR Applications

Design Medical Device UIs in 5-9 for Human Working Memory

AI and Accessibility

Update: Brazil Registrations and Foreign Medical Device Regulators

Wiklund’s Perspective on Product Capabilities, Complexity and Intuitiveness

Consultation to Extend Brazil GMP Certificate Validity for MDSAP Submissions

Dark Mode vs Light Mode for Medical Device UIs

How to Lead and Moderate a Usability Test

RAPS Convergence 2023: Until We Meet Again Next Year

EC adopts exceptions to contact lenses and UDI-DI assignment

New European Guidance Clarifies Medical Device Software Requirements

Thailand FDA and Singapore HSA Regulatory Reliance Program

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