design & validation

Accelerating Development Timelines

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.

Robling Medical workers packaging medical devices


We ensure seamless progress throughout your project, guiding you every step of the way.

End to end capabilities: Design and Validation - Ensuring Seamless Project ProgressEnd to end capabilities: Design and Validation - Ensuring Seamless Project Progress

Driving Towards Commercial Success

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's Design and Development - Focus on Validation Planning and Long-Term Manufacturing Parameters with Collaborative Engineering and Quality Teams
Robling Medical - Excelling in Post-Design Freeze Steps for Reliable High-Quality Manufacturing Ramp-Up

Seamless Transition to Production

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.

Solving your medical device challenges. Today.