Katrina’s Blog™
Insightful News and Commentary
On leadership, product innovation, talent cultivation, and ecosystem development across drugs, devices, diagnostics, and digital health tools.
Join us as we explore the latest trends and share expert insights to help you navigate the ever-evolving landscape of healthcare innovation.
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Use Quality Principles to Blast Past Compliance Into Excellence
The FDA has long supported a quality approach to improve the safety of medical products. The Case for Quality captures the continuing efforts to encourage medical device manufacturers to apply quality principles to their products and operations. The program was...
The Increased Role of International Harmonization Efforts in FDA
It appears to me that the FDA is increasing its use of medical products harmonization document as a source for regulatory guidance in recent years. For example, during the Pharmaceutical Quality Symposium in October, Tara Groen and Rapti Maudurawe of the FDA noted the...
The Compliance Program Guidance Manual Guides Inspections
Similar to the MAPP discussed in a previous post, the Compliance Program Guidance Manual (CPGM) contains the instructions used by FDA personnel to perform the agency’s compliance work. Unlike the MAPP, the instructions in the CPGM are more like FDA guidance in that...
Understanding CDER Through Its Policies and Procedures
An organization with a robust quality system will have established policies and procedures, so it should be no surprise that CDER has a full set. By law, these must be available to the public, so they have been published on the CDER website as the CDER Manual of...
Cybersecurity for Medical Devices Part 2
Conduct Your Risk Assessment Using the CVSS Standard Management of cybersecurity across the lifecycle of a medical device includes repeat assessments of the device’s vulnerabilities, categorization of their severity, and prioritizing risk mitigation and controls. The...