The article covers additional questions industry representatives may have with respect to informed consent and specific aspects associated thereto. In particular, the aspects addressed include the involvement of children and non-English speakers. Table of Contents...
The article addresses the aspects related to the responsibilities of the parties involved in clinical investigations, namely, study sponsors and clinical investigators. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
Sometimes, managing medical device submissions can feel like dating in high school- lots of rejection. In an industry where regulatory compliance comes with the highest stakes, it’s surprising that failure to comply with submission requirements is so...
Previously in 2014, the FDA has published a final guidance discussing premarket expectations but the constant technology advancements and changes requires a new guidance. As a result, on October 18, 2018, the FDA published a draft guidance about cybersecurity and it...
European trade association, MedTech Europe, published a detailed plan. It aims to help the member states speed up and simplify the process of implementation of new MDR/IVDR regulations. The plan intends to assist states and national medical regulating authorities by...