Introduction to the Final Guidance FDA recently published a final guidance document, “Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.” This question-and-answer formatted document aims to clarify and provide...
When it comes to the medtech space implementing the second half of a 19-point action plan from the Medical Device Coordination Group, it’s pretty much yellow – or slow – across the board. At least that’s the assessment by notified body BSI Group. The MDCG’s plan,...
