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… read more →
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… read more →
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)… read more →
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… read more →
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… read more →
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… read more →
By Laurel Hacche and Debra Cortner, SQA Associates ANVISA (Agência Nacional de Vigilância Sanitária) There were no updates for ANVISA for October 2020. http://antigo.anvisa.gov.br/updates China Guidances and Regulations Regulation of… read more →
By Laurel Hacche and Debra Cortner, SQA Associates Eudralex – Volume 4 – Good Manufacturing Practice (GMP) Guidelines and Annexes There were no updates noted for Eudralex – Volume 4… read more →
Association for the Advancement of Medical Instrumentation (AAMI) AAMI News: Draft Guidance ‘Leapfrogs’ FDA into Regulation of Brain – Computer Interfaces, April 2019 For people affected by paralysis or an… read more →
Wins & Challenges Out here in Los Angeles, we’re used to summer weather starting around now, but I still find myself reaching for a jacket every morning. Despite our lack… read more →