Gastrointestinal Stent approval in Spain

I am moving forward with a therapeutic medical device designed specifically for highly specialized surgical procedures to be used in Spain. The core concept is defined, but I now need an experienced collaborator to help translate that concept into a market-ready product that satisfies Spanish and broader EU medical-device requirements. Project Status: The device design is finalized (Patent Pending). We are looking for a certified partner to perform or coordinate the following validation steps: • Biological Evaluation (ISO 10993): Specifically the Biological Evaluation Plan (BEP) and Report (BER) to justify safety without extensive new chemical characterization, if possible. • Physical/Functional Testing: Tensile strength, flow rate, and collapse resistance testing (we can provide the test protocols). • Sterilization & Shelf-Life: Support with validation protocols for EtO sterilization and accelerated aging. Key areas I want your support on include: • Refining the device’s technical specifications so they align with advanced surgical workflows. • Preparing the full design-history documentation (risk analysis, usability engineering, verification and validation plans). • Guiding me through ISO 13485 and CE-mark compliance steps relevant to therapeutic, class-appropriate devices destined for operating theatres in Spain. • Generating manufacturing-ready CAD files and accompanying drawings, ensuring tolerances and materials match specialised surgical use. • Advising on sterilisation, packaging and labelling that meet Spanish hospital standards. Acceptance criteria: all files and reports must be delivered in English (Spanish translations are welcome), formatted for immediate submission to a Notified Body, and organised so that each requirement of the Medical Device Regulation (MDR 2017/745) can be traced back to the corresponding evidence. If you have a proven track record bringing therapeutic surgical devices to Spain, I’m ready to review your approach and timeline.

N° de projet : 40241979

Localisation : Spain