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Regulatory Impact Assessment; How are you handling this currently?

Regulatory Impact Assessment (RIA) need not be fully integrated into the regulatory policy processes from the beginn…
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Small/Mid-Size Firms: Take Low-tech, Low-cost Path for tech/software for your process

Too often, small and mid-size companies are intimidated by the costs, complexity, and long implementations… It’…
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FDA: Software Assurance guidance for Production and Quality System Software

This draft guidance is intended to: Computer Software Assurance is a risk-based approach to establish confidence…
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Language requirements for Manufacturers – Europe

Different legal provisions outlined in Regulation (EU) 2017/745 on medical devices (MDR) permit Member States to est…
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Mexico: Modifications to Medical Device Registration

In August 2023, the COFEPRIS, the Mexican Regulatory body in charge of the regulation of Medical Devices, updated th…
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