Regulations
eIFU Requirements Under the EU MDR and Regulation 2021/2226
What is an eIFU?
In general, an eIFU is d…
eIFU for Medical Devices: Country Specific Regulations and Benefits
There are several benefits of using electronic…
Regulatory Impact Assessment; How are you handling this currently?
Regulatory Impact Assessment (RIA) need not be…
FDA: Software Assurance guidance for Production and Quality System Software
This draft guidance is intended to:
Comput…
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