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
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
The EU MDR requires manufacturers to develop and maintain comprehensive technical files that demonstrate a medical deviceâs compliance with safety, performance, and post-market surveillance requirements.
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
This document outlines a stability program to ensure drug product quality over time. It covers method validation, protocol development, shelf-life determination, and ongoing monitoring, following
Despite the long run up to preparations, it can still feel like youâre not prepared for EU MDR compliance. With the new MDR deadline rapidly
With the merger of BioAssist and QualityHub, BioAssist Founder and President Rebecca Fuller has become their newest Consulting Director.
Conducting effective remote audits require a good deal of organization both before and during the audit to ensure adequate preparation of the audit team, effective
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