The Business Of Biotech’s Cell & Gene Miniseries opens with Dr. Carsten Brunn, president and CEO of Selecta Biosciences. Guest host Erin Harris joins our discussion on Selecta's ImmTOR platform and how the company is addressing the immunogenicity of AAV vectors challenge faced by gene therapy companies. Listen now and subscribe so you never miss an episode.
By Jayet Moon, author of the book Foundations of Quality Risk Management
The thread of risk management connects every piece in the quality management system and guides the manufacturer in quality-related decision-making throughout the lifecycle of the device. In Part 3 of his article series on risk-based post-market surveillance (PMS) in the age of EU MDR, Jayet Moon discusses how quality risk management and PMS are natural partners. He also examines the five elements for which the PMS system should be on the lookout.
It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.
MRI machines use a strong magnetic field and computer-generated radio waves to produce cross-sectional images. Thus, the quality of the MRI depends on the uniformity of the magnetic field and the radio components inside it.
This interview with Isabel Wahl, head of Evonik’s RESOMER development laboratory, discusses the use of a new bioresorbable copolymer that combines mechanical strength with rapid degradation for wound healing and pediatric devices.