Dedicated to design & manufacturing for medical device
14-16 September 2020 | SWEECC H2&H4
Quality Control
2019.07.18 Implementing the IEC 60601-1 Medical Electrical Equipment Standard Why a mobility classification matters and how to choose the right one. Read More
2019.07.10 The Pros and Cons of Standardized Testing Is a standard test necessarily the right test? Read More
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. Read More
2018.03.27 Putting the ‘Management’ into Quality Management System Three ways to demonstrate management oversight within your QMS. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More