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.
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
Guide to US FDA Requirements for Novel and Innovative Medical Devices
This white paper covers the US FDA regulations for manufacturers of novel and innovative medical devices and technologies.
US FDA and MDSAP Inspections for Medical Device Manufacturers
Prepare for US FDA and MDSAP inspections and help meet compliance with our expert guide.
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
Meeting Global Regulations and Expectations for HFE
Meet the human factors engineering (HFE) expectations, regulations and standards of a global marketplace.
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.
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.
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.
Overview of Japan IVD Registration
In this on-demand webinar, our Emergo by UL expert will outline the latest insights into Japan IVD registration.