Platomics
@platomics.bsky.social
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Platomics automates regulatory processes and connects in vitro diagnostic manufacturers, laboratories and regulators to accelerate compliance and bring innovation to patients, faster. www.platomics.com
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Platomics is collaborating with #Diaceutics to double up on our shared goal of providing labs with resources and solutions to facilitate bringing precision medicine diagnostics to patients faster. ( @dxrx-labnetwork.bsky.social )

Access the report:
DXRX- The Diagnostic Network
Access the latest IVDR report from DXRX- The Diagnostic Network
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Risk management under #IVDR
How #labs might deliver on a rather tall order

The IVDR has reshaped lab compliance and put out a tall order for labs to serve up. One aspect that proves particularly exasperating is a much stronger emphasis on rigorous risk management.
More bread and butter, please: Risk management under IVDR  - Platomics
How labs might deliver on a rather tall order  The IVDR has reshaped lab compliance and— let’s just admit it—put out a tall order for labs to serve up. One aspect that proves particularly…
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Validation under ISO 15189 vs. performance evaluation under IVDR

Before IVDR, many EU labs routinely validated their lab-developed tests in the course of following ISO 15189. And so the assumption may be that following the method validation approach of this ... (Read more: https://buff.ly/4i4clhU)
Is an ounce of validation enough? - Platomics
Validation under ISO 15189 vs. performance evaluation under IVDR Before IVDR, many EU labs routinely validated their lab-developed tests in the course of following ISO 15189. And so the assumption…
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Not sure how to begin #IVDR documentation of your in-house tests?

Our interactive wizard will get you started with basic IVDR know-how and then lead you straight to the right strategy for your lab.

Click here: https://buff.ly/4gKEzNF
ISO 5649 -- A beautiful standard?

Learn more about this global standard that lays out requirements for assuring the quality, safety, performance and documentation of laboratory-developed tests.

Visit our blog:
ISO 5649: A beautiful standard that points the way toward IVDR compliance - Platomics
Platomics PlatoX® platform is tailored to guide you through IVDR technical documentation for your in-house tests.
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The three pillars of performance evaluation

1. Scientific validity requires a thorough literature search
2. Analytical performance entails experiments with reference samples
3. Clinical performance is demonstrated in experiments with clinical samples

Read more here: https://buff.ly/4i4clhU
Our lab solutions also benefit #manufacturers!
#IVDR

EU labs and IVD manufacturers are both subject to strict new IVDR requirements. Labs are now considered the manufacturer of their in-house tests.
For Manufacturers - Platomics
Platomics regulatory services and the PlatoX® platform simplify and accelerate compliancefor your lab customers
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Regulatory ratatouille for labs – What needs to go in the pot?
Our first French language webinar on IVDR, ISO 15189 and Co.

Register: https://buff.ly/3EEPM5l

#IVDR
As of May 26, 2024, EU labs are to have fulfilled all but one of the IVDR Article 5.5 requirements.

Platomics offers solutions that support labs in fulfilling each lab requirement, enabling a faster and more efficient compliance path.

#IVDR #IVDReady