CRABCLAMP+
Evolution of the CRABCLAMP: sterile single-use medical device for handling tubes, catheters and guidewires.
CRABCLAMP+ - VBDEVICES is the evolution of the CRABCLAMP: a sterile single-use medical device designed to secure and ease the handling of tubes, catheters and guidewires during endovascular procedures.
MeDev Consulting carried out the development, industrialization and CE MDR marking of the CRABCLAMP+ medical device, building on the manufacturing and market experience of the CRABCLAMP.
It produced the Technical File documentation for the notified body, together with the AEMPS notification and the market-placement notification in RECOPS.
Class Is medical device, NB 2797 BSI.
Role of MeDev Consulting: Device development, sterilisation validation, technical file, notified body assessment, CE MD certificate (NB 2797 BSI), EUDAMED registration, AEMPS licence, industrialisation and ongoing manufacturing. ISO 13485 quality system certification. Post-market surveillance (PMS), post-market clinical follow-up (PMCF), person responsible for regulatory compliance (PRRC) and registration card (TR) for the AEMPS.