Dedicated to design & manufacturing for medical device
14-16 September 2020 | SWEECC H2&H4
2019.07.18 Implementing the IEC 60601-1 Medical Electrical Equipment Standard
Why a mobility classification matters and how to choose the right one.
2019.07.10 The Pros and Cons of Standardized Testing
Is a standard test necessarily the right test?
2019.02.27 Applying Quality Management Best Practices for Medtech
A look at how one medical device manufacturer automated quality management along with ideas on how shared intelligence can drive quality from the shop floor to the top floor.
2018.03.27 Putting the ‘Management’ into Quality Management System
Three ways to demonstrate management oversight within your QMS.
2018.03.27 IQ, OQ and PQ: The Backbone of Your Quality System
Know how IQ, OQ and PQ—the three essential elements of a Quality Assurance System—govern the medtech sector.
2018.03.27 Medtronic Exec: How to Move Past Compliance to Quality
The medical device industry has had a tough time recently when it comes to its reputation for addressing defects.
2018.03.27 Philips Forced to Stop Making AEDs Until Problems are Fixed
FDA and Philips reached an agreement regarding manufacturing issues involving the company's automatic external defibrillators.
2018.03.27 Faulty Seal Blamed for Sterlimed Agilis Recall
FDA has identified the recall as a Class I, the most serious type of medical device recall.
2018.03.23 The Necessary Overhead of Quality Processes in Medical Device Product Development
The Necessary Overhead of Quality Processes in Medical Device Product Development
2018.03.20 Why Is Quality Focusing on Compliance?
Excessive focus on compliance can create hurdles in cultivating quality and innovation.