SQA Regulatory Surveillance Summary 5 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary #5, 2021 International Organization for Standardization (ISO) Extra Guidance on Food Safety: A New Handbook to Accompany ISO 22000 Has Just Been Published, 09 March 2021 Keeping food safe involves the combined effort of every single player in the food production […]
SQA Regulatory Surveillance Summary 4 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary #4, 2021 Agência Nacional de Vigilância Sanitária (ANVISA) Brazilian Regulators Update Economic Monitoring Requirements for Some Medical Devices, 26 March 2021 ANVISA has issued new regulations regarding economic monitoring of certain device types in order to boost transparency and establish reference […]
SQA News | Spring 2021
Wins & Challenges Spring greetings! First I want to convey my best wishes to all the Mothers out there for the recent Mother’s Day! We had a great time celebrating with my Mom and Carrie with the rest of the family. Being able to do this was largely made possible by the different vaccines being […]
SQA Regulatory Surveillance Summary 3 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary #3, 2021 European Commission (EC) – Biologics Commission Extends Transparency and Authorization Mechanism for Exports of COVID-19 Vaccines, 11 March 2021 The EC has extended until the end of June 2021 the transparency and authorization mechanism for COVID-19 vaccine exports. This […]
SQA Regulatory Surveillance Summary 2 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary #2, 2021 International Organization for Standardization (ISO) Clinical Investigation of Medical Devices for Human Subjects, ISO 14155:2020, November 2020 ISO 14155:2020 addresses good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to […]
SQA Regulatory Surveillance Summary 1 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary, #1 2021 Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA has Published its Annual Management Plan (PGA) for 2021, which Comprises 61 Goals and Actions, 16 December 2020 The driving principles of the ANVISA Annual Management Plan (PGA) are to increase efficiency, […]
SQA News | Year End 2020
Wins & Challenges In SQA’s 25 years, we’ve never seen the changes and challenges like those we’ve been through since the last newsletter. Like most businesses, we’ve had our share of struggles and wins, but to stay on the right side of the equation, we’ve had to pivot in several key areas along the way. […]
SQA Regulatory Surveillance Summary | December 2020 –
By Laurel Hacche and Debra Cortner, SQA Associates SQA Regulatory Surveillance Summary for December 2020 European Commission New Technical Guidance on Cosmetic Hand Gels Addresses Antibacterial and Antiviral Claims, 25 November 2020 The European Commission has issued a new technical document agreed by national authorities and stakeholders that further clarifies which claims producers of cosmetic […]
North America Outlook Magazine
SQA was featured in Issue 1 of the North America Outlook Magazine, a digital and print publication that reaches an audience of more than 220,000 people across the region. For more information, click the link below.
SQA Regulatory Surveillance Summary | November 2020 – copy
By Laurel Hacche and Debra Cortner, SQA Associates Association for the Advancement of Medical Instrumentation (AAMI) Remote-Controlled Hospital Devices Get COVID-19 Guidance, 28 October 2020 AAMI has published a new consensus report (CR), detailing guidelines for the implementation of remote control for many critical medical devices. Notably, the U.S. Food and Drug Administration (FDA) has […]