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The Blog

Selected category: Regulatory compliance

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Mind the gap: How to navigate the IVDD-IVDR transition – Part 2

By Laura Nea

The global trend toward more stringent regulatory control of in vitro diagnostic (IVD) medical devices is sending shock waves through the industry. Now that we have passed the halfway mark in the transition to Europe’s new In Vitro...

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IQ, OQ and PQ for automated liquid handling – a key to success of your instrument and project

By Severin Heynen

Successful scientific projects build on accurate results from analytical methods that you have confidence in. In regulated situations, they must be backed up by routines and documentation that follow regulatory standards that...

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The regulation of lab developed tests: an uncertain future

By Nicholas Smith

If the U.S. Food and Drug Administration (FDA) goes forward with its proposed guidance to regulate laboratory developed tests (LDTs) in the same way it does manufacturer-derived tests, then much is going to change for clinical...

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The regulation of lab developed tests: How not to inhibit advances in personalized medicine

By Nicholas Smith

The intention by the U.S. Food and Drug Administration (FDA) to issue a new guidance that would bring oversight of laboratory developed tests (LDTs) directly under FDA regulatory control, instead of the current paradigm in which...

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Navigating the Future of Laboratory Developed Tests - The Impact of New FDA Guidance

By Nicholas Smith

Uncertainty and concern best describe the prevailing feelings of many researchers, clinicians, and companies that develop, manufacture, and implement laboratory developed tests (LDTs). The reason for all this uncertainty is the...

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