Tag: medical device manufacturing

Industry Focus Areas, Medical

FDA extends pandemic-era policy allowing certain device, production changes without prior approval

November 2, 2023

Via: MedTech Dive

The guidance, first issued in May 2020, was supposed to expire at the end of the public health emergency. The policy allowed for any required production process changes, like social distancing, or manufacturing changes due to supply chain shortages, which […]

Industry Focus Areas, Medical

Pandemic Pressures & Their Ripple Effects on Medical Device Materials

March 30, 2022

Via: Design News

Navigating FDA’s strict and ever-changing regulatory requirements is far from a new balancing act that medical device manufacturers face daily. But the many pressures born from the pandemic, such as supply chain disruption coupled with the stringent regulatory environment, have […]

Industry Focus Areas, Medical

Improving efficiency in medical device manufacturing

March 9, 2022

Via: Manufacturing Tomorrow

At the Medical Expo MD&M West 2022 at booth 3097 (April 12 – 14, 2022, in Anaheim, CA, U.S.A.), Kistler will showcase its broad range of process monitoring and measurement solutions for medical device manufacturing. Visitors will be able to […]

Design & Planning, Process

Preparing Your Manufacturing Business for Natural Disasters

January 18, 2022

Via: Design News

In 2017, Medtronic was significantly impacted by multiple natural disasters all in the same fiscal quarter, but managed to weather those disasters by bending, not breaking. While we have not seen any reports yet of any medical device manufacturers being […]