R&D/New Product Development We lead in R&D and new product development, specializing in design, prototyping, and testing for medical devices. With a focus on innovation and precision, we collaborate closely with clients to transform ideas into market-ready solutions. Our proven track record includes developing cutting-edge designs, rapid prototyping, and rigorous testing for safety and efficacy.
Product Service At Lumin Innovations, we specialize in manufacturing state-of-the-art medical LCD displays that set the standard for quality and performance. With over 30 years of industry experience, our products are designed to meet the stringent demands of the medical field, providing unmatched reliability and precision.
Quality Engineering Quality is our priority, with rigorous quality management practices, risk assessment, and statistical analysis to validate designs and processes. We adhere to regulatory standards and industry best practices, ensuring every device meets stringent quality and safety standards.
Manufacturing Line Setup We excel in setting up advanced manufacturing lines tailored to medical device production needs. From layout design to equipment selection and validation, we ensure efficiency, compliance, and scalability. Our commitment to excellence extends to clean room design, equipment installation, and comprehensive training for optimized productivity and quality.
QMS Setup We specialize in designing and implementing robust Quality Management Systems (QMS) compliant with ISO standards, FDA regulations, and industry guidelines. Our comprehensive solutions include document control, CAPA processes, training, and supplier qualification for optimized performance and regulatory compliance.
Process Development Our process development expertise focuses on optimizing workflows and ensuring regulatory compliance. Using advanced quality engineering techniques and data analytics, we drive continuous improvement and cost-effective manufacturing. Our services cover risk assessment, quality control, and streamlined processes for consistently high-quality products.
Remediation We excel in swift and effective remediation strategies, addressing non-conformities and regulatory deficiencies. Our transparent and collaborative approach ensures rapid resolution, process improvement, and sustained compliance.
Audit Preparation Our meticulous audit preparation services guarantee readiness and confidence during regulatory audits. We conduct thorough gap analyses, mock audits, and documentation support for compliance and risk minimization.
Help with Audit Findings We assist in interpreting audit findings, prioritizing corrective actions, and implementing CAPA plans for sustainable improvement. Our focus on preventive measures and proactive solutions helps maintain compliance and enhance quality management systems.
