As the FDA prepares to retire its longstanding Quality System Inspection Technique with the rollout of the new Quality Management System Regulation, QSIT creator and
The FDA’s Quality Management System Regulation, effective Feb. 2, replaces the agency’s traditional Design Controls with ISO 13485–aligned Design and Development activities, marking a significant
Five FDA officials answer questions from medical device manufacturers about the agency’s Quality Management System Regulation, or QMSR, which goes into force for industry on
The FDA’s new Quality Management System Regulation, effective Feb. 2, will allow the agency to review a medical device manufacturer’s internal and supplier audit findings
An effective CAPA system is critical for MedTech manufacturers to meet FDA and ISO requirements and avoid costly compliance failures. This article outlines five expert
Effective management control is essential for medical device companies, as FDA views executive leadership as ultimately responsible for quality system performance and many deficiencies stem
The FDA’s recent warning letter to a wearable technology company signals that the agency may heighten scrutiny of devices offering features such as blood-pressure estimation
After acquiring another company, MedTech and pharmaceutical manufacturers should carefully evaluate and harmonize quality management systems by blending the best practices from each to build
The FDA urges medical device makers to prepare now for the new Quality Management System Regulation. Though similar to ISO 13485, compliance requires active effort.
User-related errors in medical device use are a critical focus in risk analysis, where human factors engineering aims to minimize these errors through intuitive, user-centered