
Health Canada Medical Device Regulations (MDL, MDEL, SaMD)
Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients.
... Read moreIntroduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients.
... Read moreThe FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
... Read moreOn June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices
... Read moreWho Needs an MDSAP Certificate? Anyone looking to manufacture a Class II, III or IV medical device in Canada requires
... Read moreHealth Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug,
... 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.