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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.
Continuous Medical Education
We offer a comprehensive platform for continuous medical education, helping healthcare and laboratory professionals stay up to date with the latest research, regulatory requirements, and evolving standards in the medical field.
Our commitment to quality
and data security
ISO 13485-certified quality management system since 2018
Services are housed in an ISO 27001-certified data center in Vienna
Current Webinars
ISO 15189 passed, IVDR failed?
Join our upcoming Platomics webinar as we discuss one of the most persistent misconceptions in diagnostics:
the belief that ISO 15189 accreditation alone makes a laboratory compliant for in-house devices under the IVDR.
We’ll break down the overlap, expose the gaps, and show what Article 5(5) really expects from diagnostic laboratories.
Whether your lab builds, modifies, or adapts its own tests, this session will help you understand the In-House IVD trap
and how to avoid it with structure, transparency, and smart digital support.
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