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 […]
Whitepapers
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 […]
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 […]
Discover the Future of the Medical Device Industry
This year means new trends for your industry. Read “5 Top Medical Device Industry Trends to Plan for in 2020” for a glimpse of what your business can expect to see in the coming months. With an early look at updated regulations, powerful new revenue sources and more, the information in this industry brief can […]
Data Technologies Improve the Way You Do Business
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 […]
ePTFE for the Cardiovascular Device Industry
For over 35 years, ePTFE has been a mainstay of the cardiovascular device industry. The physical properties of ePTFE make it highly suitable for use in implantable vascular devices. Choosing an ePTFE provider like BD Peripheral Intervention OEM helps ensure a streamlined process and a finished device that meets expectations.
Ultimate Guide to a Digitized Shop Floor
As Industry 4.0 initiatives and digital transformation efforts get off the ground, ongoing advances in Industrial Internet of Things, artificial intelligence and robotic process automation are making their mark on everything from product assembly to quality inspection to equipment maintenance and even good manufacturing practice (GMP) documentation. It’s no wonder that leading manufacturing companies today […]
Is Your Software HIPAA-Compliant?
Build HIPAA compliant software with the latest guide from Catalyst UX, a leader in UX for medical and life sciences. Whether you need to update legacy software, move to mobile or launch a new digital solution, you’ll want to read this guide. We cover what HIPAA is, who is affected, how HIPAA impacts UX design, […]
3 Tech Trends That Will Accelerate Manufacturers’ Time to Market
The medical device manufacturing market is expected to exceed $600 billion globally by 2025, but this rapid growth is accompanied by unprecedented levels of technological innovation. Read “3 Tech Trends That Will Accelerate Manufacturers’ Time to Market” to see the new advancements driving the industry and what they can offer your business. Download the brief […]
