
EUA FDA Transition Plan for Medical Devices in 2022
In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
... Read moreIn response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
... Read moreHow Medical Devices are Classified in Canada Regulatory Classification Basics for your Medical Device: There are certain rules that apply
... Read moreOn December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices
... Read moreInterim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim
... Read moreThe advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes
... Read moreIt’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
... Read moreAs of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of
... Read moreRecently in Canada, the Minister of Health has signed an Interim Order to allow expedited access to COVID-19-related medical devices
... Read moreQuality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.