We support each project with a proven process flow, designed to guide you to your next milestone, no matter where you find yourself in your design, development, and manufacturing process.
We ensure seamless progress throughout your project, guiding you every step of the way.
What sets Robling Medical’s Design and Development work apart is our collective focus, from the very beginning, on validation planning & long-term manufacturing parameters.
Our Engineering and Quality teams work with you hand-in-hand through your development stages, capturing critical design inputs and turning them into robust, ISO-13485 compliant design solutions.
Drawing upon our extensive knowledge of medical material sciences and component design, we partner to ensure your product is safe, reliable, and ready for regulatory submissions.
Robling Medical excels in all post-design freeze steps to ensure reliable, high-quality ramp-up of manufacturing in a controlled and consistent state.
Product and Packaging Functional Testing
Equipment, Tooling and Process Validation (URS, IQ, OQ, PQ)
Assembly and Process Qualifications and Validations
In-house Packaging Design and Validation
Distribution Simulation Studies
Shelf Life Studies (Accelerated and Real Time)
Sterilization Validation (EtO, Gamma and E-Beam)
Robling has partnered on hundreds of products through this process.