Supplier Equipment Qualification and Its Impact on Packaging Specifications

Blog header image with the title ‘Supplier Equipment Qualification & Impact on Packaging Specifications’ over a background of medical device equipment, featuring the SQA Services logo

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, […]

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 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 […]

SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA Regulatory Surveillance Summary for July and August 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner   Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Carries Out Health Inspection Actions in Food Supplement Industries in Rio de Janeiro, 10 July 2023 During the week of 12-16 June 2023, ANVISA and state and municipal health surveillance […]