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Bahrain Medical Device Registration Guidelines
To assist medical device manufacturers in maintaining compliance with applicable requirements, the National Health Regulatory Authority (NHRA), the Kingdom of Bahrain’s agency responsible for medical device regulation,...
MedTech Europe Warns on MDR Implementation Issues
MedTech Europe, the association of companies that operate on the medical device market, is deeply concerned with the current situation regarding the implementation of Regulation 2017/745 (MDR). The association warns...
FDA Guidance on Application Requirements for Devices
The Food and Drug Administration (FDA), the US agency responsible for medical device regulation, issues guidance dedicated to requirements for certain Class II applications. Medical Devices for Percutaneous Coronary...