At the start of this year, IMARC Research conducted a survey of over 100 clinical research professionals representing sponsors, sites, and contract research organizations (CROs), to learn more about how others in the industry see the future of monitoring. This whitepaper examines the findings and provides guidance for how the industry can adapt to new […]
An Overview of IEC 60601-1 3rd Edition, 2nd Amendment
The 2nd Amendment of IEC 60601-1 3rd Edition includes several changes and clarifications that you will need to be aware of to ensure your product remains compliant to regulatory requirements. Stay ahead of the curve with our overview of the key changes. Download this white paper…
Best Practices Guide for Writing Requirements
Better requirements lead to clearer, more effective communication between stakeholders. This drives the entire organization toward greater transparency, less rework, and, accelerated development… without sacrificing quality. While writing requirements is both an art and a science that will vary by context, there are a few best practices to consider. In this eBook, we’ll cover: How […]
Application of Risk Analysis Techniques in Jama Connect™ to Satisfy ISO 14971
This paper takes you through the main clauses of ISO 14971 — the FDA’s mandatory standard for risk assessment in medical devices — and outlines how Jama Connect gives you a comprehensive way to manage risk and requirements throughout development. Learn how to: Understand ISO 14971 and FMEA Identify, analyze and mitigate risk Connect risks […]
State of the Art – Best Practices and Literature Review Using DistillerSR
To comply with the MDR and the MEDDEV 2.7/1 rev 4 guidance document, manufacturers are expected to demonstrate that they have conducted a thorough clinical evaluation of the device. As part of this systematic process, manufacturers are required to conduct a thorough analysis of the current state of the art, to comply with the number […]
The Evolving Role of Thermoforming Suppliers in Medical Packaging Design
Nelipak Healthcare Packaging is a global technology provider of innovative custom medical packaging solutions. Our rigid and flexible packaging is designed based on market expertise from concept to the point-of-use. We combine superior quality and protection, customer support and the most efficient technology to deliver the best total value. Download this white paper…
Avoid MDR Delays with Proper Technical Documentation
Prior to marketing a medical device, manufacturers must comply with applicable conformity assessment procedures set out in Annexes IX to XI of (EU) 2017/745 Medical Devices Regulation (MDR). Medical Devices Notified Bodies like BSI and manufacturers have a shared interest in proper Technical Documentation (Summary of Technical Documentation, dossier, technical file, renewal application, etc.) submission […]
How the Role of Regulatory Operations Professionals Will Evolve
Medtech companies have experienced more regulatory changes in the last two years than in the last 20. With EU MDR on the horizon, the role of the regulatory professional will expand as they now have an increased impact on business decisions. Read this report, including insights from Alcon, to understand the shift in the medical […]
Digital Transformation in Healthcare
There are four key enabling technologies that are helping power the growth of digital transformation.These technologies include: IoT devices, artificial intelligence, big data and elastic cloud computing. At Catalyst UX, one of the leading UX firms for medical and life sciences, we have seen substantial growth of digital transformation in IoT-connected devices and AI-related skills. […]
Leading Healthcare UX Design Trends
Every year at Catalyst UX we do a roundup of what we see as the top UX trends for the coming year. Our picks are basedon experience we have with our clients in medical and life sciences, financial services and other work in IoT and cloud. Largely, UX trends are driven by macro changes in […]
The Medical Device Maker’s Guide to Customizing Linear Motion
Designing and manufacturing medical and life sciences devices is always a challenge. Linear motion components with the required form, fit, and function are often vital parts of these devices. Most such components are bought off the shelf. But what if standard linear motion products don’t work, or don’t fit, or can’t deliver quite the right […]
