From initial planning to assuring on-time delivery, Jenitek effectively manages the supply chain in accordance with requirements of ISO9001, ISO13485, ISO14001, FDA 21CFR Part 820, and EU MDD 93/42/EEC. We develop, verify and approve our suppliers as well as monitor and measure any changes to products.
Supplier control is a key link for our supply chain management system. It ensures that all critical suppliers maintain a quality management system. Supplied components are appropriately qualified, safe, meet customer requirements and are effective in medical devices. Within the supplier control, if any links of the supply chain are broken, it could slow customer market time or even wipe out the whole plan which is completely unacceptable.
In addition to building close relationships with an approved supplier, all key materials, components and new technology must be reviewed and verified in advance. For further risk reduction, all key materials and components must have two or more approved suppliers.