Class I – III Medical Device Consulting and Support
Whether you are a start-up that wants to turn a novel idea into reality or an established organization looking for support, IPS can develop your product from ideation through manufacturing and beyond. Regardless of where you are in the development, approval or commercialization phase of your product, IPS experts will develop tailored strategies to efficiently achieve regulatory approval, clinical study execution and implementation of the right Quality Management System. In addition to a full suite of quality solutions, IPS also provides gap assessments and preparation services for transition from EU IVDD to IVDR.
As a trusted partner, IPS’ industry-leading MedTech experts have successfully supported clients by effectively navigating FDA 483s, Warning Letters, Recalls, Competent Authority interactions, and Notified Body Non-Conformance responses. Our DOD-level security measures, meticulous data management and statistical analysis, trusted collaboration and proactive communication, and robust quality control measures ensure an elevated standard of service experienced by all of our clients.
As a trusted partner, we also help optimize R&D costs and improve supply chain efficiencies by leveraging new technologies and partner ecosystems. Additionally, our Subject Matter Experts are well-equipped to provide technical staffing services for a wide range of positions within the device, combination product, and technology-related industries.
