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
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.