Are your Products EU IVDR Compliant?
Experience
Confidence & Certainty
in EU IVDR Compliance
with Tata Elxsi
Over a span of the last 2 years
Technologies Covered
Point-of-care | Hematology
Clinical Chemistry | Microbiology
Molecular biology | Immunology
Lab Automation | General Reagents
Credentials
500+ Technical Documents Remediated
100+ Performance Evaluation Documents Designed
200+ Labels Re-designed
100+ Packaging Configurations Re-designed
Key Areas Addressed
![Risk Management-240x240 Risk Management-240x240](https://service.tataelxsi.com/hs-fs/hubfs/Risk%20Management-240x240.jpg?width=240&name=Risk%20Management-240x240.jpg)
Risk Management
Risk Management is mandatory for all IVD products and is necessary to enhance the safety & performance of the device by assessing and mitigating the risks and hazards associated with it. Tests are performed based on all foreseeable risks, during the entire lifecycle of a device in order to prevent IVDs from failing during use and to ensure that users receive error-free test results.
![Performance Evaluation-240x240 Performance Evaluation-240x240](https://service.tataelxsi.com/hs-fs/hubfs/Performance%20Evaluation-240x240.jpg?width=240&name=Performance%20Evaluation-240x240.jpg)
Performance Evaluation
The performance evaluation report is a novel, one of the most critical, and a mandatory requirement under the EU IVDR. It establishes scientific validity for the correlation of analyte & clinical condition, assesses analytical performance, and demonstrates the clinical performance of the IVDs.
![Post Market Surveillance Post Market Surveillance](https://service.tataelxsi.com/hs-fs/hubfs/Post%20Market%20Surveillance-240x240.jpg?width=240&name=Post%20Market%20Surveillance-240x240.jpg)
Post Market Surveillance
Post Market Surveillance (PMS) is a continuous process of gathering and analyzing data from IVD use with a focus on proactive measures. PMS processes have become more stringent, and it is imperative to have a proper system for the entire process including complaints handling and reporting.
![General Safety and Performance Requirements General Safety and Performance Requirements](https://service.tataelxsi.com/hs-fs/hubfs/General%20Safety%20and%20Performance%20Requirements-240x240-1.jpg?width=240&name=General%20Safety%20and%20Performance%20Requirements-240x240-1.jpg)