Supplier Audits: Are Your Supplier Quality Audits Providing Measurable Outcomes?
Effective supplier audits are the backbone of a reliable, compliant supply chain. By strategically assessing your suppliers’, your organization can identify risk early, ensure alignment with industry standards, and strengthen every link in your supply network.
Regulatory Compliance in Life Sciences: Challenges and Best Practices
Many organizations manage the fundamentals—routine calibrations, label checks, and process logs—but achieving true compliance in life sciences requires going beyond the checklist.
Join SQA at Generis American Medical Device Summit
SQA Services is sponsoring the Generis American Medical Device Summit 2025 in Chicago. Join our Lunch & Learn Roundtable on supplier management with Gilberto Jimenez and discover strategies to ensure global medical device quality and compliance.
Get to the Root Cause in Medical Device Manufacturing
Prevent recurring issues in medical devices with RCCA—drive compliance, quality, and patient safety.
Key Insights from the 2025 PDA Regulatory Conference
Highlights from the PDA Regulatory Conference: AI in compliance, predictive quality, training evolution, and FDA inspection readiness strategies.
Supplier Equipment Qualification and Its Impact on Packaging Specifications
In the life sciences industry, packaging is far more than a box or a seal. It is a validated system—a safeguard designed to maintain sterility, preserve product integrity, and meet the rigorous requirements of ISO 11607 and FDA regulations. Yet one of the most overlooked risks in this space comes from a seemingly routine event: […]
The Importance of Requirement Consumption by the Supplier for New Product Launches
Bringing a new device to market is one of the most critical milestones for any manufacturer. It’s a driver of growth, innovation, and improved outcomes. In the highly regulated medical device industry, it’s a process with zero margin for error. From concept design to commercial release, every step must comply with strict FDA, ISO 13485, […]
Why PPAP Is Critical for Medical Device Manufacturing
Implementing PPAP effectively doesn’t just reduce regulatory risk—it can save time and money across the medical device industry supply chain.
SQA Regulatory Surveillance Summary for 3Q/4Q 2024
Review key 2024 regulatory shifts still influencing 2025—covering pharma, medical devices, AI, cosmetics, and global compliance strategies.
SQA Regulatory Surveillance Summary for May and June 2024
SQA Regulatory Surveillance Summary for May and June 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA will use Analysis of Equivalent Foreign Authorities for Inspection and GMP Certification Process, 03 May 2024 In the Official Gazette of the Union, ANVISA has published the Normative Instruction (IN) 292/2024, which […]