Regulated product manufacturing
ISO 13485:2016 & ISO 9001 certified, FDA registered

Planet Innovation has its own internal manufacturing division for the manufacture of regulated products. The team has considerable experience managing ISO 13485:2016 compliant medical device contract manufacturing utilizing lean manufacturing principles.

Our experience includes transferring biomedical instruments covering immunoassay, molecular diagnostics, haematology, microbiology automation and histology to manufacture, and distribution to global markets.

LEAN PRINCIPLES

We apply lean manufacturing principles to achieve improvements in productivity, quality, reliability and lead-times by eliminating waste and optimizing operations. These principles include single piece flow, visual management, Kanban materials supply and continuous improvement.

CO-LOCATION

Planet Innovation’s facilities have co-located IVD instrument manufacturing and development teams for fast transfer to manufacture and continued support of medical instruments.

We frequently provide a combination of development and manufacturing supply services to our clients in order to optimize reliability and robustness and manage the delivery of high quality products to their end customers.

COMPLEX IVD

Our team support the manufacture of a diversified portfolio of products spanning small, low-complexity devices to very large floor-standing instruments.

We provide dedicated, degree-qualified product managers to also oversee the production of any sterile consumables and software products.

Our team also has extensive experience in establishing manufacturing operations in both developed and low-cost regions, for clients around the world.