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MHRA Guidance on Medicines and Medical Devices
MHRA Guidance on Medicines and Medical Devices  The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical devices regulation, published updated guidance on distinguishing...
Team NB Position Paper on Dental Implants
The European Association of Medical Devices – Notified Bodies (Team NB) issued a position paper describing the application of an exemption rule regarding the endosseous dental implants and dental implant abutments....
FDA Policy on Diagnostics Testing for COVID-19
The Food and Drug Administration (FDA), the US authority responsible for medical device regulation, issued guidance for clinical laboratories dedicated to Coronavirus Disease-2019 during the public health emergency....
FDA Guidance on Third Party Review Program
The Food and Drug Administration, the US authority responsible for medical device regulation, issued guidance dedicated to the Third Party (3P510k) Review Program allowing recognized third parties to perform the review...
FDA Guidance on Electrosurgical Devices
The US Food and Drug Administration (FDA), the authority responsible for medical devices regulation, issued guidance dedicated to 510(k) premarket notification submissions for Electrosurgical devices for general...