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…
Speeding up MDR Technical Documentation approval
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 accelerating the review of Technical Documentation (Summary of Technical Documentation, dossier, technical file, renewal […]
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 […]
Active Implantable Medical Devices – Evaluation & Testing Requirements
Active implantable medical devices(AIMDs) are complex products subject to rigorous regulatory standards by authorities across the globe. With both implantable and non‐implantable factors, as well as EMC and wireless considerations, manufacturers have a lengthy list of standards to know and to which they must comply. It is important to know which standards and requirements apply […]
Building the Engineering Team You Need
A key challenge facing business and engineering leaders today is talent acquisition and retention. Unemployment is at a nearly 50-year low at 3.7 percent, and if you focus on engineering specifically, the rate is a meager 1.8 percent. In a recent Congressional Research Service report, it was estimated that science and engineering jobs will increase […]
