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 […]
The medical device market in Europe is growing fast and is expected to reach $61.4 billion by 2025, up from $48.9 billion in 2020. A large aging population, demand for more surgical procedures, and technological expansion are driving this trend. The Medical Device Directive (MDD) is a legal framework that includes three directives that are […]
Editor’s Note: This posts on EU MDR was originally published here by MedTech Drive and written by Greg Slabodkin. Dive Brief: While the Medical Device Regulation’s May 26 go-live date marks a significant milestone, MedTech Europe warned in a statement that MDR challenges remain, limiting the industry’s ability to “seamlessly supply certified devices under the new rules.” The European trade […]
With President Biden signing the new Executive Order on Improving the Nations’ Cybersecurity. I thought it would be worthwhile explaining how Jama Connect can be used by both Cloud Service Providers (CSPs) and Third Party Assessment Organizations (3PAO) to accelerate and automate development of FedRAMP compliant and authorized offerings. For those unfamiliar with FedRAMP, it […]
What is FMEA (Failure Mode and Effects Analysis)? Failure Mode and Effects Analysis (FMEA) is a structured process for determining potential risks and failures of a product or process during the development phase. FMEA teams examine failure modes—those potential points of failure in a product or process — and what the failure effects (risks, harm, […]
Toys to Tools – Keeping Pace with eVTOL Certification Standards Today’s market for electric vertical takeoff and landing (eVTOL) is one of the most innovative and fast-moving in the aerospace industry, so keeping pace with ever-changing eVTOL certification standards is no easy endeavor. eVTOL Applications The military led the way in eVTOL by transforming drones […]
Editor’s Note: This posts on autonomous vehicle development was originally published here by EE Times and written by Junko Yoshida. While this post was published in 2020, the content is still relevant to AV development in 2021. How many safety standards does it take to screw in the lightbulb in a highly automated vehicle? A few years ago, […]
Ensuring Aerospace Compliance to Regulatory Requirements We are in a time of unyielding technological development. It is not unlike the “giant leaps” made by the US Space program in the 1960s. The technology available to us in our everyday lives and certainly in the Aerospace and Defense industry is staggering. Think about when you got your first cell phone. Remember […]
In this post, we review the details of the latest product roadmap enhancements related to baselines and how these changes benefit our customers.
In this post, experts from LHP Engineering Solutions examine the difference between being ISO 26262 compliant and being ISO 26262 certified.