New requirements you should know for medical EMC

Plan now to ensure your medical devices comply with new EMC requirements by the December 2018 effective date. Since the development cycle can be 2-3 years, it is important to understand the new IEC 60601-1-2 EMC 4th Edition standard now when designing medical devices. To provide you guidance on these important changes and improve your

Total disc replacement could have a problem: Here’s why

Total disc replacement (TDR) has the potential to replace fusion as the gold standard for treatment of painful degenerative disc disease. However, complications after TDR have been associated with wear and tear, including accelerated polyethylene wear. Retrieval data published in 2012 revealed that the wear and tear, called impingement issues, have occurred in many designs, which can lead

Electric medical device regulatory standards have changed: Here’s how

Dirk Smith, Co-founder of Minnetronix Medical devices in 2016 continue to benefit from dramatic technology developments across engineering disciplines. Electronic-based devices, in particular, are increasingly employing cutting-edge technologies to meet user demands for fast, multi-function, usable, safe and cost-effective products. As complexity in devices and technology rapidly evolve, regulatory requirements are following suit, with significant

ISO gives pharmaceutical industry new management tool to improve patient safety

by Garry Lambert, ISO Focus The benefits of implementing Good Manufacturing Practices and quality management are henceforth made easier to achieve for the pharmaceutical sector thanks to a new standard from ISO (International Organization for Standardization). “The standard is of vital importance to the pharmaceutical industry and its suppliers of pharmaceutical primary packaging materials. For

Expert commentary on ISO 13485:2016 is now available

The third edition of ISO 13485 has now been published. With extensive changes to the scope of the standard, understanding the full extent of the impact on your organization can be a challenge. BSI has released expert commentary on the changes in the new standard which gives you a great understanding of the updated version. Download here