Are your Products EU IVDR Compliant?
Over a span of the last 2 years
Point-of-care | Hematology
Clinical Chemistry | Microbiology
Molecular biology | Immunology
Lab Automation | General Reagents
500+ Technical Documents Remediated
100+ Performance Evaluation Documents Designed
200+ Labels Re-designed
100+ Packaging Configurations Re-designed
Key Areas Addressed
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.
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 (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.