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 has uncovered widespread data integrity issues in medical device submissions, particularly from third-party labs, including two in China. As a result, the agency
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.
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
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
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
This guideline provides best practices for writing clear, effective, and compliant Standard Operating Procedures (SOPs) in pharmaceutical and medical device manufacturing. It covers authorship, structure,
This guideline highlights the importance of CAPA systems in pharmaceutical and medical device manufacturing to ensure regulatory compliance and product safety. It explains how CAPA