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 […]
Whitepapers
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 […]
Adapting to Pharma’s Next Normal – 2021 Pharmaceutical Trends
If your company has felt the impact of the COVID-19 pandemic, you’re not alone. The pharmaceutical industry is changing in a big way, but there are new tools and technologies ready to help you be more resilient and adaptable than ever before. Download “Adapting to Pharma’s Next Normal – 2021 Pharmaceutical Trends” to see the […]
Learn What Quality Trends to Watch for in 2021
2020 was a year of disruption for the industry, but the need to ensure a consistent and high level of quality across the product life cycle hasn’t changed. Read “Shaping the Next Normal for Quality and Compliance” to see what the future holds and how you can utilize new trends to master change at your […]
Leading Medical UX Trends
A great way to stay competitive is to innovate with UX Design. There are 7 trends we’re seeing in the medical and life sciences industry that can help your business continue to grow and stay ahead. Virtual healthcare, artificial intelligence and predictive analytics continue to grow, but other trends are emerging as well. Check out […]
Mastering Data to Drive Medical Device Innovation to 2030
As more life sciences manufacturers go paperless, they’re seeing the benefits of better information, automated systems and a digitized infrastructure. Read “Mastering Product Life Cycle Data to Drive Medical Device Innovation to 2030” to learn how these new forces will drive industry growth into the next decade and beyond. If you have questions ~ or […]
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…
Quality System Metrics That Matter
Without effective quality management, it’s impossible to take full advantage of the advanced technology driving the industry today. Read “Quality System Metrics That Matter” to see the exciting results other quality organizations have experienced with MasterControl’s quality solutions and the impact you can expect if you make the switch. If you have questions ~ or […]
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 […]
