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Blog
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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 establish national language requirements for makers of device companion materials. …
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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 the Guidance Document by defining types and impact of product or organizational ch…
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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 two equally important forms: effort to perform and effort to improve.
Team’s l…
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Swissmedic Device/IVD Database Key Dates
Swissmedic now handles registration of economic operators, medical devices and In-vitro diagnostic medical devices directly, since the agreement on mutual recognition of conformity assessments (MR…
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- Clinical Automation (8)
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- Labeling (14)
- Regulations (13)
- Regulatory Automation (8)
- Regulatory Information Management (9)
- UDI (5)
- Writing (8)