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Save time, resources and costs For your lab
Platomics offers an automated regulatory platform designed for generating IVDR documentation, plus the know-how for getting the job done.
The IVDR transition rollout is now almost complete
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.
Whether you need a detailed understanding of the requirements, a tool for documenting your in-house tests, validation services, or a solution for reaching ISO 15189 conformity—we’ve got you covered.
Reach compliance for your tests
PlatoX®
PlatoX® automates and accelerates IVDR compliance for your lab’s in-house diagnostic tests, equipping you with audit-ready documentation faster.
Our digital solution enables your lab to quickly and confidently navigate complex requirements.
Among others, the following IVDR requirements are covered:
- GSPRs: Document that each of your tests meets the IVDR General Safety and Performance Requirements
- Risk management: For lab designed tests, also aligned with ISO 22367
- Essential regulatory files: Including intended purpose, risk classification, performance evaluation, etc
- Workflow documentation: Create IVDR specification documentation, using relevant product data from manufacturers accessible on the platform
- GSPR public declaration: Download our template to create a declaration of GSPR conformity
UNDERSTAND THE REQUIREMENTS
IVDReady Webinar Series
Get the regulatory know-how needed for IVDR compliance and find out how our platform can navigate you there
The IVDReady webinar series covers the basic knowledge needed for reaching compliance, with a special emphasis on documenting your lab designed tests.
The series also introduces the PlatoX® regulatory platform and its software that enables the efficient generation of IVDR documentation for lab-developed tests.
PlatoX® NGS Workflow
1. Define your diagnostic workflow
Use our intuitive setup guide.
2. Execute and analyze
Perform your experiments, upload the data, and our high performance bioinformatics pipeline runs the analysis and calculates the performance parameters.
3. Generate and customize reports
Generate detailed compliance reports tailored to meet specific needs and regulatory requirements.
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
Get in touch
Platomics GmbH
Jakov-Lind-Strasse 15/3
1020 Vienna
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