[GUIDE] ISO 13485 for Medical Device Development
In this blog, we introduce ISO 13485 and untangle everything your medical device development team needs to know about the important standard.
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2022 Predictions for Medical Device Development: Increased Focus On Cybersecurity, Clarity On Standard Compliance, and the Challenge of Human Variability
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 new landscapes and will […]
Key Takeaways: What the New Medical Device Regulations (EU MDR) Mean for You
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 […]
Regulatory Shift for Machine Learning in Software as a Medical Device (SaMD)
Machine Learning in Software as a Medical Device Machine learning (ML), a subset of artificial intelligence, has become integral across software in all industries, and the medical and life science spaces are no exceptions. ML can help medical systems improve the identification and diagnosis of disease, create personalized medicine, and help with drug discovery and […]
MDR Challenges Remain as Regulation Goes Into Effect: MedTech Europe
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 […]
Lessons Learned: Medical Device Development Through COVID-19 and Beyond
Editor’s Note: This posts on lessons learned around medical device development during COVID 19 was originally published here by MedTech Intelligence and written by Josh Turpen, Jama Software’s Chief Product Officer. In the fall, I wrote about how the medical technology industry has struggled to keep pace with other, similar industries. In the piece, I discuss how important it is […]
The Top Trend for Medical Devices in 2021? Putting Quality First
In this post, experts explain why a keen focus on quality is the top trend for medical device development in 2021, and how teams can prepare.
Navigating Medical Device Compliance: 6 Key Tips
Based on our work with hundreds of medical device developers, we’ve compiled this guide to navigating the complexity of medical device compliance.
What Phases are Needed for Developing a Medical Device?
What Phases are Needed for Developing a Medical Device? Developing a medical device is an inherently complex process, and one that’s becoming more complicated all the time. In addition to the increasingly stringent regulatory requirements that must be met for FDA approval and/or EU MDR compliance, medical device manufacturers must also navigate ongoing changes […]