IVD experts who support manufacturers
As the healthcare landscape evolves, the demand for accurate and reliable diagnostic solutions has never been greater. IVD manufacturers face unique challenges due to the complex and constantly evolving global regulatory requirements, such as the US FDA, EU IVDR, and the new UK MDR. At the same time, the IVD industry is rapidly evolving with new diagnostic test technologies and an increased use of software and AI solutions. On top of that, there is rising pressure on cost and reimbursement rates for diagnostic tests in many markets, creating the need to achieve and maintain operational efficiency in a highly competitive industry.
Qserve has a dedicated team of IVD experts who support IVD manufacturers with tailored services across the entire product life cycle. Next to advice on strategies for global regulatory compliance, we help IVD manufacturers with the design of analytical and clinical studies, generation of technical documentation for IVDR conformity assessments and FDA regulatory submissions, and support authorization and execution of clinical studies. We assist in interactions with Notified Bodies and Regulatory Authorities, ensure supply chain actors meet regulatory obligations, and help set up and maintain compliant systems for QMS, IVD risk management, and post-market surveillance. We work with all IVD manufacturers - start-ups, SMEs, large global manufacturers - and all IVDs, including Point-of-Care and Companion Diagnostics. All our staff have hands-on experience in the IVD industry.
