by Katrina Rogers | Jan 30, 2020 | Product Development
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...
by Katrina Rogers | Jan 28, 2020 | Product Development
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...
by Katrina Rogers | Jan 23, 2020 | Product Development, Uncategorized
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...
by Katrina Rogers | Jan 21, 2020 | Medicine, Product Development
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...
by Katrina Rogers | Jan 16, 2020 | Medical Products, Product Development
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...
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