[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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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 […]
Complying with FDA Design Control Requirements Using Requirements Management Principles
Complying with FDA Design Control Requirements Using Requirements Management Principles Mercedes Massana: So agenda for today is we’re going to talk a little bit about the design controls and what they are. We’re going to talk about requirements management and what that is. And then we’re going to talk about how the two relate to […]
Why Startup Medical Device Companies Should Prioritize Requirements and Risk Management Before QMS
As a medical device product development consultant, I often see start-up companies having trouble deciding what to prioritize – design controls and risk management or the quality management system (QMS). And what they mean specifically is, which software systems should the company invest in first – the requirements and risk management solution that will aid […]
Ensuring FDA Compliance for Your Digital Health Solution
Over the last decade, digital health solutions have become increasingly important, powering revolutionary developments in areas such as robotics, genomics, diagnostics, patient/provider interactions, and many more. In our recent webinar with MDM Engineering Consultants and BeanStock Ventures, we talked about critical standards and best practices to follow. Attendees also heard critical insight from industry leaders […]
EU MDR: What You Need to Know
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 […]
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 […]
2021 Predictions for Medical Device Product and Systems Development
In this post, subject matter experts from Jama Software and Beanstock Ventures discuss predictions for medical device product and systems development in 2021 and how they might impact the way your team works.
How Jama Software’s TÜV SÜD Certification Helps Customers Build Safer Products
In this post, we discuss our partnership with internationally-recognized testing body TÜV SÜD, and how it helps our customers bring safer products to market.
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.