Case Study: Large Medical Device Company achieves fast cleanroom kitting and compliant fulfillment with RR Donnelley

Cleanroom Kitting and Assembly Solution for Medical Device Manufacturer

Large Medical Device Company chose to outsource manufacturing so it could stay focused on R&D, marketing, and customer service, but needed a fast six-month ramp-up for a regulated medical device operation. RR Donnelley was tasked with supporting a new FDA-registered ISO 14644-1 Class 8 cleanroom environment while handling sourcing and procurement, regulatory quality management, order entry, warehousing, and fulfillment.

RR Donnelley provided an integrated cleanroom kitting and assembly solution from its FDA-registered, ISO 13485-accredited, cGMP/QSR-compliant facility, including ERP integration, project management, procurement, and direct-to-hospital fulfillment. The result was faster launch readiness without major capital investment, plus lower labor and administrative costs, avoided assets and facilities spend, and the ability to scale domestically or internationally while keeping capital focused on product development and sales.