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 President & CEO Michael Guymon Shares Insights on Supply Chain Quality
In a recent episode of Bridge the Gap, hosted by Dale Zwizinski and Adam Jay from Revenue Reimagined, Michael Guymon, President & CEO of SQA Services and former leader at SpaceX and Rocket Lab, shares his insights on building systems that don’t crack under pressure—and what go-to-market teams can learn from high-stakes industries. 1. Defining Quality in […]
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 […]
SQA Regulatory Surveillance Summary for March and April 2024
SQA Regulatory Surveillance Summary for March and April 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Brazil: Agência Nacional de Vigilância Sanitária (Anvisa) Anvisa Extends the Validity Period of the Certificate of Good Manufacturing Practices to Four Years, 22 March 2024 The validity of the Certificate of Good Manufacturing Practices (CBPF or cGMP) of […]
SQA Regulatory Surveillance Summary for January and February 2024
SQA Regulatory Surveillance Summary for January and February 2024 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Publishes New Edition of the Biovigilance Manual, 17 January 2024 In Brazil, biovigilance covers a set of monitoring and control actions, ranging from donation to the clinical evolution of a recipient […]
SQA Regulatory Surveillance Summary | Monthly Update 2024
SQA Regulatory Surveillance Summary for Quarter 4, 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) Joint Operation in Foz do Iguaçu Fights Illegal Import of Products Subject to Health Surveillance, 29 September 2023 ANVISA and the Federal Revenue Service carried out a joint operation in Foz do Iguaçu […]
SQA News | Fall 2023
Wins & Challenges October marked an incredible year since joining SQA Services. I regularly reflect upon how blessed I am to be a part of this organization. We are a mighty team providing indispensable services to many of the most influential companies in the world. Earlier this year, we took time as a leadership […]