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1Blog Post

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

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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 […]

2Blog Post

FDA Outlines its Approach to Artificial Intelligence Regulation

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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 […]

3Blog Post

Navigating EU MDR Compliance: Overcoming Challenges To Sustain Your Certification

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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 […]

4Blog Post

Understanding IATF 16949: A Quick Guide to Automotive Quality Management

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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 […]

5Blog Post

Decoding The FDA’s Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma

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Decoding The FDA’s Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma The current state of validation is seen as a hindrance to quicker deployments, with an emphasis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 […]

7Blog Post

The Seven Steps to Performing FMEA

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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 […]

9Blog Post

An In-Depth Guide to IEC 62304: Software Lifecycle Processes for Medical Devices

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An In-Depth Guide to IEC 62304: Software Lifecycle Processes for Medical Devices In the world of modern medicine and healthcare, software plays an integral role in the functionality, monitoring, and management of medical devices. These software components can range from simple interfaces to complex algorithms that drive critical medical decisions. Ensuring the safety and effectiveness […]

10Blog Post

[Webinar Recap] Compliance Made Easy with Jama Connect® for Automotive and Semiconductor Development

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Evaluate Your Compliance Against ASPICE, ISO 26262, or ISO 21434 with Diagnostic Services Offerings from Jama Software® During the webinar, experts Steve Rush, Principal Consultant, and Sampath Yerramalla, Senior Consultant, explored various service offerings within Jama Connect that provide insights into compliance status against these critical automotive standards. Key takeaways from this webinar: Learn about available […]