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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
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!
August 4, 2021
An overview of the most important questions regarding the UK Responsible Person (UK authorized representative) registration with the MHRA. Our expert consultants can guide you in the grace period, classification, labeling, registration and UK Notified Bodies.
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”
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.