In this blog, we define GAMP®5, the framework for a risk-based approach, with an introduction and conclusion provided by Jakob Khazanovich, Medical Device Solutions Consultant at Jama Software®. This blog contains details sourced from the International Society for Pharmaceutical Engineering. What is GAMP®5 and How Does Its Guidance Help Regulated Companies Using Computerized Systems? When […]
Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Hali-Brite® – What Is a Vertiport: Everything You Need to Know – originally published on […]
DOD 5000 Series DOD 5000 Series consists of policy guidance and is backed by a collection of directives that describe a disciplined management approach for acquiring systems and materiel to satisfy valid military needs. Six pathways of the adaptive acquisition framework: urgent capability acquisition; middle tier of acquisition (MTA); major capability acquisition; software acquisition; defense […]
Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Security – 5 FBI Recommendations for Medical Device Cybersecurity – which was originally published on September […]
Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Medtech Insight – European Regulatory Roundup, July 2022: Threat Of Ongoing Hurdles Masks Progress – which was […]
In this blog, we introduce ISO 13485 and untangle everything your medical device development team needs to know about the important standard.
How EN 50128 Establishes Functional Safety Standards for Railway Software In increasingly complex, rapidly evolving, and highly regulated industries, product development teams must build safety-critical products, while streamlining risk management and keeping accuracy and security at the forefront. This blog post will define functional safety and EN 50128 and explain why compliance with safety standards […]
FDA Inspection Intro In Part One of this two-blog series, I shared 5 best practices to prepare your organization for FDA inspection success. Inspections by the FDA can lead to regulatory action and consequences such as warning letters, recalls, and consent decrees. Thus, you want to put your best foot forward to demonstrate the compliance […]
This is part one of a two-part series. Part two is available here. FDA Inspection FDA inspections can be daunting, especially for an organization that is expecting its first one. In part one of a two-blog series, here are five best practices to prepare your organization for success: 1: Understand why the FDA will perform […]
2022 Automotive 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 of […]
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