Latest Medical Device Industry News & Trends

Showing 6 to 10 of 33

Interview: Barry Sands - FDA clearance success

August 9, 2021

FDA De Novo 510K clearance RQMIS consultancy services - Success story by providing regulatory and quality remote full service support. RQMIS expert consultants worked to achieve the medical device manufacturer goals

Official announcement of FDA user fees 2022

August 6, 2021

FDA provided information about the annual establishment registration fees, the small business program, and medical device user fees for Fiscal Year 2022 (FDA user fees 2022), which are effective October 1, 2021, through September 30, 2022. Apply with us for the FDA small business certification / application! SBD certification is here!

Brexit: Understanding the New Requirements for Medical Device

June 29, 2021

After months of negotiations, the United Kingdom (UK) and the European Union (EU) finally reached an agreement that will define their future relationship, which came into effect at 23:00 GMT on December 31, 2020. As of this date, the UK is a “third country” from the EU perspective, and the same applies to the European Economic Area (EEA)from the UK perspective. This context has been one of great change for all businesses, in which medical devices have not been the exception. From that date, for medical devices to move between UK and EEA markets, new requirements must be met. But this not only affects England, it also affects Northern Ireland in a special way, where its situation also becomes “special”

Medical Device Swiss market - new situation

June 2, 2021

Up to this point, Switzerland have been able to be part of the EU for the Medical Devices industry. However, from the Date of Application of the EU Medical Devices Regulation (MDR) on May 26, 2021, Switzerland will become a “third country” as regards medical devices. Switzerland has the same regulatory status as UK for medical devices.