ISO 15197:2013 lays out the performance requirements and user safety criteria for blood-glucose monitoring systems intended for self-testing by patients with diabetes mellitus. It defines precision metrics, system accuracy, usability guidelines, and labelling requirements to ensure consistency, reliability, and effectiveness in real-world usage.
The standard also mandates stringent evaluation methods, including clinical trials and analytical performance assessments, to verify the accuracy of the test results across a range of glucose concentrations.
Growth Management Corporation offers end-to-end consulting services—gap assessment, documentation support, risk management planning, and audit readiness—to help you achieve ISO 15197 certification quickly and efficiently.
ISO 15197:2013 certification is essential for manufacturers of blood-glucose monitoring systems who want to access international markets and comply with healthcare regulations such as IVDR (In Vitro Diagnostic Regulation) in the EU or US FDA guidelines.
Failing to meet ISO 15197 can result in market rejections, legal issues, and patient safety concerns. Choosing this standard is not just a regulatory need—it's a commitment to quality and user health.
✅ Market Access Expansion: Enables entry into regulated international markets, including EU, US, Japan, and Australia.
✅ Brand Trust & Reputation: ISO 15197 signals quality, boosting customer confidence and clinical acceptance.
✅ Reduced Product Recalls: Minimizes risk of non-compliance and technical failures, saving cost and reputation damage.
✅ Faster Regulatory Approval: Simplifies approval processes under CE marking and other national regulatory bodies.
✅ Investor & Partner Confidence: Certified quality attracts investors, medical distributors, and institutional partners.
✅ Operational Efficiency: Streamlines your production, testing, and quality assurance systems.
✅ Increased Sales Potential: Builds consumer trust in OTC markets and strengthens your competitive positioning.
✅ Support for Future Innovations: Lays the groundwork for compliance in future IVD product developments.
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Growth Management Corporation is a management consulting firm that provides consulting, training, implementation, and certification services and solutions to organizations of all sizes, and all domains.
