IronLine’s Substack
IronLine Consulting LLCTopics related to medical devices and IVDs
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 22 | Subscribers | Read | ironlineconsulting.substack.com |
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Latest Issues
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Maria M. Chan-- a personal reflection
Maria M. Chan, Ph.D passed away on October 11, 2024. I first met Maria when she interviewed me for a scientific reviewer position in the Division of Immunology and Hematology (DIHD), Office of In Vitro Diagnostic Devices (OIVD), CDRH, FDA...
Laboratory Developed Tests - The Song Remains the Same
(from Josh): This is a guest post by Michael Wienholt, a regulatory expert and affiliated consultant with IronLine Consulting. Michael is an IVD industry veteran who has seen it all regarding LDTs-- the good, the bad and the ugly. I hope ...
PCCPs and LDTs
The draft guidance "Predetermined Change Control Plans (PCCPs) for Medical Devices" was issued by the FDA on August 22, 2024. This guidance provides recommendations for implementing predetermined change control plans (PCCPs) in medical devi...
A Cool Technology is Not Enough
On a call with a prospective client.
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