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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 […]
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 […]
In the competitive world of medical device development, medical device companies can’t afford to lag behind the pack. Streamlining the design and approval process is vital to getting products to market in a timely manner. Proper documentation is key to a smooth approval process. One essential ingredient to medical device documentation is the Design History […]
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, […]