With the introduction of its new Quality Management System Regulation (QMSR), the FDA has transitioned MedTech personnel requirements from QSR Sec. 820.25 to ISO 13485
The FDA’s new Quality Management System Regulation makes quality culture a top management responsibility, and regulators will increasingly look for objective evidence that quality is
The FDA’s Quality Management System Regulation is now in effect, requiring medical device companies to transition from the legacy QSR rule to a framework aligned
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
Former FDA investigator Lori Carr and Alson & Bird litigation attorney Dan Jarcho share their memories of US v. Utah Medical Products, a landmark GMP
Life sciences companies regulated by the FDA and other authorities must conduct audits to ensure compliance, evaluate quality systems, and mitigate risks to product safety
An FDA warning letter highlights deficiencies in a medical device company’s CAPA quality data analysis procedures, emphasizing the critical need for robust, statistically justified trending
Data integrity in FDA-regulated industries is ensured by following Good Documentation Practices and ALCOA+ principles, which require records to be accurate, complete, attributable, and secure
The EU MDR requires manufacturers to develop and maintain comprehensive technical files that demonstrate a medical device’s compliance with safety, performance, and post-market surveillance requirements.