Are your Products EU IVDR Compliant?


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 


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

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

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

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

The revised 20 General Safety and Performance Requirements (GSPRs) of the IVDR replace the 13 essential provisions of the IVDD. This has led to the implementation of requirements, with explicit detail and evidence needed for each. It is mandatory to comply with these GSPRs to receive IVDR CE certification.

We take pride in our high
Customer Satisfaction Score

Customer Testimonials

Discover More

Case Study | Blog | Thought Leadership

Case Study

Ensuring Uninterrupted Sales of Legacy IVD Devices in the EU Market


Impact of EU IVDR on Key Compliance Areas


Challenges Faced by the Manufacturers and the Role of a Remediation Partner

Are you facing any challenges in your compliance journey?

Let us know how to contact you.