Compliance vs Quality – India Edition
By Daniel R. Matlis In October, I had the privilege to visit Mumbai, India, to provide the keynote address at a series of Life-Science Executive …
Regulatory
ComplianceQuest Offers Cloud Native Enterprise Quality Management Solutions
By: Daniel R. Matlis Axendia was recently briefed by ComplianceQuest’s executive team. The team, 80% of whom have deep experience in the Enterprise Quality Management …
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FDA confirms: Hacking a pacemaker only requires commercially available equipment
By: Giselle C. Matlis, Research Assistant On August 29, 2017 the FDA published a Safety Communication, Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s …
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WHY Is Data Integrity the Foundation of Good Science?
By: Sandra Rodriguez, Market Analyst and Ellyn McMullin, Research Associate, Axendia Inc. One of the basic tenets of investigative reporting is getting to the facts …
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10 FDA Answers on ‘Driving a Culture of Quality for Devicemakers’
By: Daniel R. Matlis, President The Case for Quality: Why Does It Matter? Last month, I had the privilege to moderate a discussion with Capt. …
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CYBERSECURITY RISKS IN MEDICAL DEVICES ARE REAL
By: Eric M. Luyer, Market Research Analyst The Healthcare Industry Has a New Set of Threats on Its Hands Connected medical devices-like other computer systems-can …
QUALITY MANAGEMENT ACROSS YOUR GLOBAL SUPPLY CHAIN
How Can the Cloud Help with Data Integrity and Quality Issues Across your Global Supply Chain? REGISTER TODAY Date: MARCH 22, 2017 Time: 1:30 PM …
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Executive Doodle: The Value of Closing the Loop
What Do Executives Think About Closing the Loop? Download this Doodle based on the webinar titled “Navigating the Complexities of Med-Tech Innovation.” See why our …
The Executive View on Change Management
This 6-part video series features: The group discusses their personal experiences around change and configuration management in Med-Tech.
Hear Directly from FDA: Driving a Culture of Quality for Devicemakers
Webinar Announcement FDA and Industry Find Common Ground Driving a Culture of Quality DATE: March 1, 2017 TIME: 1:30PM Eastern Industry leaders and regulators are …
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Rapid Regulatory Changes Will Impact Medical Devices and Diagnostics Industry
By: Hugo Felix, Director Design Quality Assurance, Bard Access Systems This is Your Wake Up Call! The Medical Device and Diagnostics Industry is experiencing rapid …
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Industry Executives Discuss Change in a Complex Environment
By: Sandra K. Rodriguez, Market Analyst Life Science Industry Executive Roundtable – Event Brief Complex – the one word that accurately describes the current environment …
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