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How Will Medical Devices Be Impacted by USMCA?
Since President Trump took office in January 2017, many policy changes that affect the medical device industry have been enacted– the latest one being the renegotiation of the North American Free Trade Agreement...
The US and EU Collaborate on UDI Specifications
According to the interim report on the work of the Executive Working Group (EWG), the European Union and United States will work together to make sure their electronic database specifications for Unique Device...
Health Canada Issues New Plan for Medical Devices
On Thursday December 27th, Health Canada detailed a new three-part method aimed to help safety, oversight and quality in the Canadian medical device market. This plan has come soon after the investigation of the...
An Overview of Medical Device Regulations in the US
The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The FDA uses a risk-based classification system, which classifies medical devices into the...