The latest Platomics seminar on December 3: Proaktives Risikomanagement (in German) Register here
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 in-house tests
PlatoX® In-House Module
The PlatoX® In-House Module 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 in-house tests meets the IVDR General Safety and Performance Requirements
- Risk management: For in-house tests, also aligned with ISO 22367
- Essential regulatory files: Including intended purpose, risk classification, performance evaluation, etc
- Workflow documentation: Create IVDR specification documentation for each in-house device, using relevant product data from manufacturers accessible on the platform
- GSPR public declaration: Download our template to create a declaration of GSPR conformity to publish for each of your lab’s in-house devices
IVDR REQUIREMENTS FOR LAB QMS
PlatoX® QMS Service
Platomics offers a complete program for ISO 15189 compliance, which is now required by IVDR in most EU member states for labs performing in-house diagnostic tests. The program starts with a seminar series on ISO 15189 conformity and related RA/QM topics.
The next seminar is a German language seminar on Risk Management according to ISO 22367 on December 3, 2024.
We also offer customized solution packages, including for example support in upgrading to the latest edition ISO 15189: 2022. Contact us for more information or if your lab has any special requests. Contact us
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 in-house tests.
The series also introduces the PlatoX® regulatory platform and its software that enables the efficient generation of IVDR documentation for lab-developed tests.
VALIDATE YOUR NGS WORKFLOWS
PlatoX® NGS Validation
Validation under IVDR has become significantly more complex and includes a comprehensive documented performance evaluation. We offer a validation service for germline NGS workflows that guides you in setting up validation studies and creating the technical documentation for IVDR analytical performance requirements.
1. Plan your validation
Use our intuitive setup guide to create a validation plan.
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 validation reports tailored to meet specific needs and regulatory requirements.
We are ISO 13485 certified
Get in touch
Platomics GmbH
Jakov-Lind-Strasse 15/3
1020 Vienna
AUSTRIA
