Platomics
@platomics.bsky.social
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
www.platomics.com
#4bases and Platomics partner up to facilitate laboratory workflow documentation under IVDR
4bases and Platomics partner up - Platomics
4bases and Platomics are delighted to announce a strategic agreement aimed at facilitating laboratory regulatory documentation.
buff.ly
March 5, 2025 at 1:25 PM
#4bases and Platomics partner up to facilitate laboratory workflow documentation under IVDR
General laboratory equipment under #IVDR
Pipettes, centrifuges and the spin cycle of compliance
Pipettes, centrifuges and the spin cycle of compliance
To document or not to document? General laboratory equipment under IVDR - Platomics
Pipettes, centrifuges and the spin cycle of compliance General laboratory instruments, also known as GLUs (devices for General Laboratory Use), have a somewhat murky status under IVDR Article 5.5…
buff.ly
February 26, 2025 at 9:01 AM
General laboratory equipment under #IVDR
Pipettes, centrifuges and the spin cycle of compliance
Pipettes, centrifuges and the spin cycle of compliance
Regulatory ratatouille for labs – What needs to go in the pot?
Our first French language webinar on IVDR, ISO 15189 and Co.
Register: buff.ly/4hOK4ML
#IVDR
Our first French language webinar on IVDR, ISO 15189 and Co.
Register: buff.ly/4hOK4ML
#IVDR
Ratatouille réglementaire au labo: IVDR, ISO 15189 et cie - Platomics
La norme ISO 15189 n’est qu’un ingrédient dans la recette complexe de la conformité IVDR. Les laboratoires possédant des dispositifs internes
buff.ly
February 25, 2025 at 7:00 AM
Regulatory ratatouille for labs – What needs to go in the pot?
Our first French language webinar on IVDR, ISO 15189 and Co.
Register: buff.ly/4hOK4ML
#IVDR
Our first French language webinar on IVDR, ISO 15189 and Co.
Register: buff.ly/4hOK4ML
#IVDR
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:
Access the report:
DXRX- The Diagnostic Network
Access the latest IVDR report from DXRX- The Diagnostic Network
buff.ly
February 24, 2025 at 10:00 AM
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:
Access the report:
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.
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…
buff.ly
February 21, 2025 at 1:01 PM
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)
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…
buff.ly
February 21, 2025 at 10:00 AM
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)
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)
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
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
February 20, 2025 at 3:00 PM
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
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
Our free #IVDReady Webinar Series guides labs as they progress through IVDR documentation for their in-house tests.
Resources - Platomics
Explore Platomics' IVDReady Webinar Series to guide labs through IVDR documentation for in-house tests. Start your compliance journey here.
buff.ly
February 20, 2025 at 12:00 PM
Our free #IVDReady Webinar Series guides labs as they progress through IVDR documentation for their in-house tests.
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:
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.
buff.ly
February 20, 2025 at 9:00 AM
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:
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:
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
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
February 19, 2025 at 11:01 AM
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
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
Platomics Inks Deals With Sophia Genetics, Agilent for Automated #IVDR Compliance Documentation
via @genomeweb.bsky.social
Read more:
via @genomeweb.bsky.social
Read more:
Platomics Inks Deals With Sophia Genetics, Agilent for Automated IVDR Compliance Documentation
Through the collaborations, customers of Sophia Genetics and Agilent Technologies can use Platomics' platform to prepare documents for IVDR compliance.
buff.ly
February 19, 2025 at 8:11 AM
Platomics Inks Deals With Sophia Genetics, Agilent for Automated #IVDR Compliance Documentation
via @genomeweb.bsky.social
Read more:
via @genomeweb.bsky.social
Read more:
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.
#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
buff.ly
February 19, 2025 at 3:07 AM
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.
#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.
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
Our first French language webinar on IVDR, ISO 15189 and Co.
Register: https://buff.ly/3EEPM5l
#IVDR
February 19, 2025 at 1:25 AM
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
Our first French language webinar on IVDR, ISO 15189 and Co.
Register: https://buff.ly/3EEPM5l
#IVDR
Platomics is committed to supporting labs with the challenges of IVDR.
Learn more:
Learn more:
For Labs - Platomics
Platomics offers an automated regulatory platform designed for generating IVDR documentation, plus the know-how for getting the job done.
buff.ly
February 18, 2025 at 1:25 PM
Platomics is committed to supporting labs with the challenges of IVDR.
Learn more:
Learn more: