Sci-Lutions Ltd

Sci-Lutions Ltd is a premier medical device focused consultancy, offering a comprehensive suite of services designed to support the entire product lifecycle from concept to medical training. Our expertise encompasses regulatory compliance, navigating complex submission packages to FDA, EU-MDR, NMPA, TGA, Health Canada and others. We collaborate closely with our clients, often as an extension of their teams, to navigate complex regulatory landscapes and enhance the safety and effectiveness of medical devices. Our deep regulatory expertise, scientific rigor, and agile approach ensure we deliver solutions that not only meet compliance requirements but also exceed expectations and support better patient outcomes. We provide detailed guidance on biocompatibility and chemical-material safety evaluations, risk-based assessment pathways and complex extractable and leachable test plans for primary material substitutions. We also offer direct lines to ISO17025 compliant CRO's with fast track test options for emergency deficiency resolutions and to ensure technical documentation support, enabling clients to successfully bring innovative medical devices to market and maintain compliance throughout their commercial lifespan.