Author Bio
Ramping Up Security to Meet Operational Resilience Rules Philip Pearson, Field Chief Information Security Officer at Aqua Security, discusses how meeting operational resilience targets is crucial for effective cybersecurity measures. Operational resilience is the ability to prevent, withstand, recover, adapt and learn in the face of disruption, including cyber events. Currently, it represents a far-reaching […]
G2® Once Again Names Jama Connect® the Overall Leader for Requirements Management Software for Spring 2024 In the competitive landscape of requirements management solutions, Jama Connect® has once again emerged as the overall leader in the Spring 2024 G2 Grid® Report for Requirements Management Software. G2 rates products and sellers based on reviews gathered from […]
FDA Outlines its Approach to Artificial Intelligence Regulation “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development. U.S. regulation of artificial intelligence (AI) in medical devices will involve cooperative work […]
Manage by Exception: Data-Driven Practices to Improve Product, Systems, and Software Quality Requirement errors in product development cost time and money and create potential liabilities. The expense of these errors can make up between 70% and 85% of all rework costs. When leaders don’t have data related to the execution process, teams aren’t tracing requirements […]
Understanding ISO/IEC 27001: A Guide to Information Security Management In today’s interconnected world, the importance of securing sensitive information cannot be overstated. Organizations face numerous threats to their information assets, ranging from cyberattacks to data breaches. To address these challenges, many businesses turn to internationally recognized standards for information security management, with ISO/IEC 27001 standing […]
Navigating EU MDR Compliance: Overcoming Challenges To Sustain Your Certification Since the introduction of the EU MDR in 2017, the medical device industry has learned just how challenging obtaining initial MDR certification truly is. According to a survey of notified bodies, the number of certificates issued as of June 2023 covers roughly one-third of the […]
Best Practices for Writing Requirements “Needs.” “Features.” “Requirements.” Regardless of what terminology your teams use to identify and define requirements, the purpose of good requirements is to create a shared understanding of the promise, functionality, appearance, and value for the products you develop across all stakeholders. In this insightful session, our industry experts will guide […]
Cybersecurity Concerns for Manufacturers in 2024 The more networked and data-centric manufacturing becomes, the more manufacturing leaders ought not consider cybersecurity as something that only concerns the IT department. New SEC reporting rules and high-profile hacks against manufacturers with multimillion-dollar price tags last year curtly demonstrate the point. Org-wide planning provides the best defense against […]
Understanding IATF 16949: A Quick Guide to Automotive Quality Management In the ever-evolving landscape of the automotive industry, ensuring product quality and safety is paramount. One key standard that plays a crucial role in this pursuit is IATF 16949. In this article, we will delve into the intricacies of IATF 16949, exploring its significance, key […]
Decoding The FDA’s Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma The current state of validation is seen as a hindrance to quicker deployments, with an emphasis on adhering to thorough documentation practices instead of building systems that align effectively with their intended use. A risk-based approach to validation has been around […]