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
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.
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.
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Customer Testimonials
"I want to say a special word of thanks to the Tata Elxsi team and leadership for the overall execution of the IVDR program. The team demonstrated great maturity in understanding the many dimensions & complexity of the IVDR program and proactively addressed the challenges with their technical competence, project management, proactive communication, and timebound execution."
- EU IVDR Program Director, A Leading US-based IVD Device Manufacturer
"We benefited greatly from Tata Elxsi’s ability to quickly deploy specific technical expertise. With the help of its large offshore team, Tata Elxsi is able to deliver not just strategies and concepts but also prioritized and remediated high-volume documentation. Tata Elxsi’s project management is impressively professional, deliverables were transparent and timelines were constantly met."
- Head of Regulatory Affairs, A Leading Germany-based Healthcare Solutions Provider
"Tata Elxsi understands the challenges of markets and possesses comprehensive capabilities from concept development to engineering and the launch of medical products that meet regulatory standards. In our strategic mission to develop and launch a Lab-in-a-Box product, we are delighted to have the right partner in Tata Elxsi."
- Chief Executive Officer, A US-based Medical Diagnostic Start-up
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Case Study
Ensuring Uninterrupted Sales of Legacy IVD Devices in the EU Market
