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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This draft guidance is intended to: Computer Software Assurance is a risk-based approach to establish confidence…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 Mexican regulatory authority for medical devices, COFEPRIS, released an updated guidance documen…
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Is Regulatory Team Overworking but Unproductive?

We’re taught from an early age that hard work is key for success. What we’re not taught is that hard work comes in t…
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