Archive for category: Compliance & Regulation Page 3

Category: Compliance & Regulation

Mastering ISO/IEC 27001: A Guide to Information Security Management

May 22, 2024 in , /by

Mastering ISO/IEC 27001: A Guide to Information Security Management Understanding Information Security Management Information security, often referred to as cybersecurity, is a critical aspect of modern technology and business operations. It encompasses the protection of sensitive data, systems, and networks from unauthorized access, disclosure, disruption, modification, or destruction. The evolution of information security practices has […]

FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests

May 14, 2024 in /by

FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests Today, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns […]

What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security

May 7, 2024 in /by

What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security Managing risk around a medical device’s entire lifecycle has become increasingly complex. Many devices use third-party components, which is especially true for devices that require a network to operate. This increased need for connectivity, along with other emerging threats, is putting security at the […]

Critical Alignment for Security, Safety, & Product Teams in Automotive Development

April 25, 2024 in /by

Critical Alignment for Security, Safety, & Product Teams in Automotive Development As automotive product development becomes increasingly complex with multiple standards for compliance, alignment between different teams is more critical than ever. Yet in many organizations, specialized teams such as cybersecurity, safety, product development, and even project management work separately. In other cases, teams may […]

FDA Outlines its Approach to Artificial Intelligence Regulation

April 16, 2024 in /by

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 […]

Navigating EU MDR Compliance: Overcoming Challenges To Sustain Your Certification

April 4, 2024 in /by

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 […]

Understanding IATF 16949: A Quick Guide to Automotive Quality Management

March 14, 2024 in /by

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

March 7, 2024 in /by

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 […]

The Seven Steps to Performing FMEA

February 22, 2024 in /by

The Seven Steps to Performing FMEA Welcome to this deep dive into the world of FMEA Failure Mode and Effects Analysis (FMEA) is a powerful tool used in various industries to identify and mitigate potential failures in a process, product, or system. In this blog, we will take a detailed look at the seven steps […]