Robling Medical offers comprehensive engineering services in support of bringing your medical device to market. We can complement your own engineering staff at any point or provide complete solutions throughout your design & development, scale-up, validation, manufacturing, packaging, sterilization, and distribution processes.
PRODUCT DESIGN & DEVELOPMENT
Our engineering and regulatory staff will work hand in hand with your staff through your development stages, capturing critical design inputs, and turn them into robust design solutions. Drawing upon our extensive knowledge of medical materials, components, and processes used to produce medical devices for a wide array of procedures, we will ensure not only that your product is safe and reliable, meeting your design requirements, but is also ready for regulatory submissions.
- ISO 13485 Compliant Design Control
- Design History Files
- Product Requirements Specifications
- dFMEAs
- Design For Manufacture and Assembly (DFMA)
- CAD Models and Engineering Drawings Finished Device and Components
- Design Reviews
- Design Verification & Validation
- Device Master Record
- Packaging Design
VERIFICATION & VALIDATION
Robling Medical’s Validation Engineers ensure all processes and equipment are properly validated and maintained in order to assure all product is manufactured in a consistent and controlled state. Validations are conducted in accordance with FDA and ISO 13485 regulations.
From equipment sourcing to protocol execution and report generation, RMI can help you every step of the way.
Robling offers adoption of our existing validated processes that may be applicable to your product design in order to save you validation costs and time and get your product to market faster.
- Equipment, Tooling and Process Validation (URS, IQ, OQ, PQ)
- DOE (Design of Experiments)
- Assembly and Process Qualifications and Validations
- Packaging Design and Validation
- Product and Packaging Functional Testing
- Distribution Simulation Studies
- Shelf Life Studies (Accelerated and Real Time)
- Sterilization Validation (EtO, Gamma and E-Beam)
- pFMEA (Process Failure Mode and Effects Analysis)
- Statistical Analysis and Reporting
- Continued Process Verification
- Equipment Maintenance