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Transforming Regulatory for In Vitro Diagnostics
Platomics automates regulatory processes and connects in vitro diagnostic manufacturers and laboratories to accelerate compliance and bring innovation to patients, faster.
Our mission
Innovation to patient, faster
Recent EU regulation meant to ensure maximum benefit to patients has brought some unintended consequences in the healthcare sector. Health institutions such as hospitals and labs struggle to maintain compliance due to a lack of knowledge and resources. This bears the risk of reducing the overall offering in diagnostics, ultimately impacting quality of care and patient outcomes.
At Platomics, we address this problem by creating digital and educational services that make complying with a wide range of regulations easier and more efficient.
Platomics for labs
Platomics is committed to supporting labs with the challenges of IVDR.
Platomics for manufacturers
Making lab compliance easier for your customers can benefit your business.
Our commitment to quality
and data security
ISO 13485-certified quality management system since 2018
Integrated Risk Management Framework covering software lifecycle (ISO/IEC/IEEE 16085:2021),
cybersecurity (ISO/IEC 27001:2022) and operational risks (ISO 31000:2018)
Currently pursuing ISO 27001:2022 certification
Services are housed in an ISO 27001-certified data center in Vienna
IVDReady webinar series
June 20, 2023
IVDReady by May 2024 with Platomics
Our kick-off webinar introduces IVDReady, a free one-year program that guides labs to full IVDR compliance.
July 6, 2023
1. Let’s talk strategy
The first thing your lab needs is a strategy for documenting workflows — whether you’ve got 50 or 250 in-house tests.
July 25, 2023
2. Give it a purpose
Ready to start documenting an in-house test? It all begins with the intended purpose.
Aug 29, 2023
3. Perplexity is the beginning of knowledge
The regulatory knowledge base available to you through the IVDReady program and our regulatory platform, PlatoX IVD Assistant.
Oct 12, 2023
4. Gate opening: Introducing the Workflow studio
Workflow Studio quickly allows your lab to create compliant workflows by integrating manufacturers’ components plus the required documentation from the manufacturer.
Jan 30, 2024
5. GSPRs are challenging, standards are beautiful
GSPRs are challenging, and therein lies the beauty of established standards: they are state-of-the-art and as such can reliably fulfill the GSPRs.
Mar 12, 2024
6. An ounce of validation
We’ll explain how to fulfill both IVDR and ISO 15189 requirements regarding verification and validation, and how there is no “one size fits all” on this issue.
Apr 30, 2024
7. The real risk is not managing risk
Labs will need to have a robust risk management process in place to meet the requirements and ensure safety and reliability for patients.
Jul 9, 2024
8. IVDReady to go
Our final webinar will offer an outlook on important aspects for remaining IVDR compliant, including up to date information about the final phase of implementation.
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Get in touch
Platomics GmbH
Jakov-Lind-Strasse 15/3
1020 Vienna
AUSTRIA
