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Compliance Management Solutions

How Climate Change is Impacting Management System Standards

In February of this year, the International Organization for Standardization (ISO) and the International Accreditation Federation (IAF) introduced 31 amendments to existing and new Management System Standards (MSS) that revolved around a prominent social issue that is not typically associated with MSS: Climate Change. Summary of Changes The amendments were announced in a joint communication... Continue reading

Security Focus: Continuous Improvement in Legacy-Laden Environments

Technology environments rarely exist in a pristine, perfectly updated state. More often, they resemble bustling cities, layered with historical architecture (legacy systems) and sleek skyscrapers (modern tech). While the allure of modern technology and services is enticing, neglecting existing infrastructure can create its own set of challenges. Because organizations tend to put more resources into... Continue reading

Quality and Information Security Management Systems

Integration of Quality and Information Security Management Systems

In the dynamic and highly regulated realm of life sciences, where innovation meets precision, the implementation of robust, efficient management systems is indispensable. Two critical pillars in this regard are the Information Security Management System (ISMS) and the Quality Management System (QMS), governed by ISO 27001 and 9001. When implemented properly, these standards function hand... Continue reading

FDA Updates “Ensuring Cybersecurity of Medical Devices”: Simple solutions using your current Quality Management System

FDA Updates “Ensuring Cybersecurity of Medical Devices”: Simple solutions using your current Quality Management System

On December 29, 2022, the Consolidated Appropriations Act, of 2023 was signed into law by the United States Congress. This massive, $1.7 trillion bill addresses a range of international and domestic issues and includes a new amendment to the FD&C Act in section 524B, Ensuring Cybersecurity of Medical Devices (section 3305). It impacts anyone seeking... Continue reading

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