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A comprehensive look at ISO/IEC/IEEE 15288 goals, standards, and tools to achieve compliance. Product development is evolving quickly; over the past few years, it’s become increasingly complex. A study of nearly 300 design and engineering professionals found that 92% of respondents say they’re experiencing at least one form of increased complexity. Moreover, 76% say they’re […]
What is the Urgency Behind Automotive Cybersecurity? From a Market Perspective: As automobiles are growing increasingly connected, digitized, and complex, automotive cybersecurity has become top of mind. Made up of hundreds of “tiny computers” – each with its own networks and servers – a singular vehicle is open to millions of opportunities for cyber-attack. In […]
2022 Airborne Predictions In many ways, 2021 was a continuation of the changes brought about in 2020, a year that’s been described as “unprecedented” and “unparalleled.” In a unique way, 2021 has offered us an idea of evolving innovations and technology on the horizon for teams across industries. These changing conditions will present a variety […]
In this post, we pull out key takeaways from a recent whitepaper written in conjunction with Beanstock Ventures on the new EU medical device regulations (EU MDR) and how they might impact medical device development. As medical device technologies have rapidly advanced in recent years, regulations governing definitions, testing, and post-market activities have struggled to […]
Design Controls have been an FDA Quality System Regulation since 1997. Having worked on developing products in the regulated medical device industry for over 35 years, I have compiled a list of the five key takeaways for implementing design controls and achieving success in commercializing medical devices: Design Controls not only help achieve regulatory compliance, […]
Behind every successful product and product launch lies a complicated process that can involve multiple oversight agencies, cross-functional teams, and stakeholders. Within an organization’s governance, risk management, and compliance (GRC) framework, product teams must pursue market innovation while remaining in compliance. Staying in compliance with the vast array of rules, procedures, and contract clauses that […]
If you haven’t already, check out Part I of our ASPICE 101 blog series to learn about what the standard is and why it’s important to automotive development, and Part II, where we examine the similarities and differences between ISO 26262 and ASPICE. In this post, we take a look at the goals of ASPICE and […]
If you haven’t already, check out Part I of our ASPICE 101 blog series to learn about what the standard is and why it’s important to automotive development. In this post, we take a look at ISO 26262 vs. ASPICE and examine the similarities and differences between these two important automotive standards. ISO 26262 vs. […]
If you’ve worked in product development for any time at all, you’ve probably heard the term “ISO” used in conjunction with the terms “standards” and “compliance” (along with a variety of four- and five-digit numbers). But what does that all mean, and how does it affect you? In this article, we will provide you with […]
In this post, experts examine how functional safety requirements fit into the larger view of organizational QMS aligned with IATF 16949.