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Devicemakers planning to market products in the European Union need to understand new EU rules that spell out when clinical research is required and impose requirements for conducting trials. Read More
Brazil’s ANVISA issued a new regulation for custom-made medical devices that includes new requirements for manufacturing, marketing and importing such devices. Read More
Some individuals “may be predisposed to develop a local or systemic immune or inflammatory reaction when exposed to certain metals contained in select implantable devices,” the agency said. Read More
An accredited testing lab may conduct testing to determine conformance of a device with at least one of the standards eligible for inclusion in the ASCA pilot. Read More