The Medical packaging solutions offered by RR Donnelley Global Turnkey Solutions are custom designed to offer optimal value. These products include: medical devices, diagnostic kits, standard and custom trays, blister packs and pouches.
Companies that compete globally must assemble and label their medical device and diagnostic products to meet the specific regulatory and regional requirements of the countries in which they are marketed. These products must be completed within a validated process with system enforced process adherence, quality control and data collection.
- FDA-registered, cGMP/QSR compliant, ISO 9001- and ISO 13485-accredited facilities in North America, Europe and Asia
- Dedicated team of medical QA/ regulatory professionals
- eDHR record keeping: 21 CFR part 11-compliant
- Full product track and traceability
- Class 100,000 (ISO Class 8) clean room facilities
- Management of sterilization (Eto & gamma) and laboratory testing