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Live Webinar Oct 11: Using a risk-based approach to comply with FDA's 21 CFR Part 11
What is Ketryx?
Connected Lifecycle Management platform for regulated medical applications
QA / RA
Dev / R&D
Upcoming & Past Webinars
Register for upcoming webinars or watch a prior recording.
Using a risk-based approach to comply with FDA's 21 CFR Part 11
October 11, 2023
Join us for an insightful and comprehensive webinar focused on Clinical Trial Data Validation, Part 11 Compliance, and Computer System Assurance (CSA). This event is designed to provide professionals in the Real-World Data/Evidence space with a clear understanding of the latest developments in clinical trial IT validation and regulatory guidance from the FDA and EMA, including the recent FDA guidance on RWD/E.
Ask Me Anything: New FDA Guidance on Real World Data / Evidence
September 7, 2023
The FDA just released its latest guidance for Real-World Data and Real-World Evidence to support regulatory decision making. Ketryx CEO Erez Kaminski and Paul Jones, former Head of the FDA Engineering Lab, will host an intimate Ask Me Anything session.
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Creating and managing the lifecycle of a medical application is expensive, time-consuming, and error-prone. But what if it didn't need to be?