At LFH Regulatory, we specialise in comprehensive performance evaluations to ensure your IVD meet all regulatory requirements and perform optimally in the market. Our expert team is dedicated to helping you navigate the complex regulatory landscape efficiently and effectively.
Why performance evaluation matters
Performance evaluation is a critical step in validating the safety and performance of your IVD. This process ensures that your device performs as intended and meets the IVDR requirements and all necessary regulatory standards, ultimately safeguarding patient safety and product efficacy.
Dr Yupei Xiao
We ensure your performance evaluation meets all regulatory requirements under the EU IVDR. This includes a comprehensive assessment and analysis of data to establish or verify the scientific validity, analytical performance, and clinical performance of your device.
Our team meticulously reviews all regulatory requirements, guidelines and standards ensuring your evaluation process is compliant, preventing delays and ensuring a smooth path to market entry.
Our structured and systematic process includes planning, data collection, and rigorous analysis. We begin with a detailed Performance Evaluation Plan (PEP) that outlines objectives, methodologies, and timelines, ensuring every aspect of the evaluation is covered comprehensively.
This systematic approach guarantees that no detail is overlooked, providing a solid foundation for your performance evaluation report.
The PEP is designed to enable a thorough and accurate performance evaluation.
It covers:
Continuous performance evaluation is essential for maintaining compliance and ensuring ongoing device safety, effectiveness and performance.
We support ongoing performance monitoring and post-market surveillance, helping you stay ahead of regulatory changes and emerging performance data. Our commitment to continuous evaluation ensures that your device remains compliant and performs as expected throughout its lifecycle.
Gap Analysis:
We start with a gap analysis to identify any deficiencies in the current state of knowledge and performance data for your device. This analysis addresses:
Resource Planning:
We also conduct a financial feasibility analysis to ensure that adequate resources are available for the performance evaluation process, including any additional testing and clinical data gathering required.
Our team is dedicated to providing responsive and personalised support.
We pride ourselves on our ability to react swiftly to the changing needs of our clients and the IVD industry, ensuring a seamless experience from start to finish.
We stay agile and adapt to the latest regulatory changes and industry trends.
Our proactive approach keeps your performance evaluation process ahead of the curve and ensures compliance with the latest standards.
Our extensive experience and success stories demonstrate our capabilities.
We have helped numerous clients navigate the complex regulatory landscape, bringing their devices to market efficiently and effectively.
Our proven track record of successful evaluations and satisfied clients is a testament to our expertise and commitment to excellence.
Our team is here to help.
Let us guide you through the complexities of performance evaluation with confidence.
At LFH Regulatory Ltd, our IVD consultants bring extensive experience and regulatory knowledge to the table.
We collaborate with a diverse array of clients, establishing connections with global regulatory bodies for efficient regulatory approvals.
Contact us today and explore how our consultancy can help you successfully navigate the intricate world of IVD regulations.
We recognise the critical importance of your QMS to your organisation, customers, patients, and regulatory agencies.
Whether you are navigating the complex UK and European markets or expanding your reach globally, our QMS expertise is tailored to meet your specific needs.
Clinical and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.
Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.
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