Quality & Certifications
Commitment to Quality, Certifications and Standards
Our international quality management standards ensure that our diagnostics and reagents meet the requirements of both clinical and research environments, providing immunologists and healthcare professionals with the confidence necessary for accurate biomarker measurement.
ISO 13485:2016 Certified Quality Management System
Our development and manufacturing process for the sTLR2 RAPID Test is governed by a fully certified and independently audited ISO 13485:2016 quality management system. This internationally recognised standard specifies requirements for a comprehensive quality management system for the design and manufacture of medical devices. Our ISO 13485 certification underscores our commitment to:
- Product Safety: Ensuring the safety and performance of our diagnostic products
- Regulatory Compliance: Adhering to national and international quality assurance systems for medical devices
- Customer Satisfaction: Consistently working to meet customer requirements and enhancing satisfaction through effective application of the quality system
- Risk Management: Implementing robust risk management processes throughout the product lifecycle
UKCA Certified In Vitro Diagnostics (IVD)
The IMIWN sTLR2 RAPID Test is UKCA certified for the semi-quantitative detection of soluble Toll-like receptor 2 (sTLR2) in plasma, conforming with the relevant medical device regulations in Great Britain, and is registered with MHRA for clinical use. The UKCA certification provides assurance of the product's performance, quality, and suitability for its intended diagnostic purpose within the UK healthcare system.
Our robust quality infrastructure and commitment to globally recognised standards ensure that the sTLR2 RAPID Test is a trusted and reliable tool for advancing immunological insights in both research and clinical practice.
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