Canada
The article provides a general overview of the approach to be followed when applying for a medical device license necessary to place a new product on the market.
Uncategorized
This blog highlights the importance of regulatory compliance for medical device manufacturers, roadblocks and key steps to navigate through them. Table Of Contents: Medical devices play a crucial role in the healthcare ecosystem, aiding in the diagnosis, treatment,...
Uncategorized
Medical device compliance is an important aspect of the medical industry that ensures the safety and effectiveness of medical devices. Medical devices range from simple instruments, such as tongue depressors, to complex devices, such as implantable defibrillators. ...
North America
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The Accreditation Scheme for Conformity Assessment...
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