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
A MedTech expert emphasizes the critical role of technical writers in ensuring clear, compliant documentation, cautioning against the use of emojis in official quality system
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
MedTech manufacturers must carefully evaluate whether device modifications, especially software updates, require new FDA pre-market authorization to avoid compliance issues during inspections. Additionally, companies should
Clear traceability between design inputs and outputs is crucial for MedTech manufacturers to meet FDA and ISO 13485 requirements and avoid inspectional observations. Properly documented
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.
CAPA deficiencies are the most frequently cited issues in regulatory inspections, highlighting the critical role of a robust, well-documented CAPA system across all areas of
QualityHub partnered with international pharmaceutical and medical device companies to proactively enhance quality systems, including CAPA overhauls, compliance plans, investigation training, and FDA inspection preparation.