Blog Category: Medical Device

Challenges, Benefits, and Future Trends in Compliance Intelligence

Medical Device

Regulatory compliance—often referred to as business compliance—covers an organization’s responsibility to follow all applicable laws, regulations, and governing standards. Compliance Intelligence tools...

Compliance Intelligence, Medical Device Industry. Compliance Intelligence, Regulatory Compliance

Modifications to Medical Device Registration in Mexico

Medical Device

In August 2023, the COFEPRIS, the Mexican Regulatory body in charge of the regulation of Medical Devices, revised the Guidance Document by defining types and impact of product or organizational modifications...

COFEPRIS, Medical Device Regulations, Medical Devices, Mexico, Regulatory Guidelines

ANVISA Updates Importation Law: Key Changes

Standards

The introduction of RDC 751/2022 was significant for the Medical Device industry because it revised Brazil’s regulatory framework after two decades of validity. Despite the controversy surrounding...

Medical Devices-USA/Europe Regulatory News – Nov 2023

Medical Device

USA Guiding Principles on Predetermined Change Control Plans for Machine Learning-Enabled medical devices FDA, Health Canada, and MHRA jointly identified 5 guiding principles (Focused and bounded,...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-October 2023

Medical Device

USA Electronic Submission Template for Medical Device 510(k) Submissions The FDA Electronic submission template for medical device guidance describes the technical standards associated with...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-September 2023

Medical Device

USA (FDA) Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors The FDA has released guidance designed to support institutional review boards (IRBs), clinical investigators,...

CE marking, Europe Regulatory News, in vitro diagnostics, Medical Devices, Regulatory News, USA Regulatory News, vigilance