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
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
In line with its 2024 goal to expand corporate social responsibility, QualityHub has achieved SBTi certification, committing to net zero greenhouse gas emissions.
QualityHub Inc. has become an employee-owned company through the establishment of an Employee Stock Ownership Plan (ESOP), empowering employees with ownership stakes as part of
QualityHub has appointed Joel Paradis as Vice President of Business Development to leverage his nearly 10 years of regulatory and compliance expertise and drive company
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
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.
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