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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 and sterile consumables. The team has considerable experience managing ISO 13485:2016 compliant medical device contract manufacturing utilizing lean manufacturing principles.

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

CO-LOCATED ENGINEERING

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 AND MEDICAL DEVICES

PI manufactures a diversified portfolio of products spanning small, low-complexity devices to large floor-standing in vitro diagnostic (IVD) instruments, as well as sterile consumables and software.

We manufacture medical products for use in various regulatory jurisdictions, including the US (FDA), Europe (CE), Health Canada and APAC region. These include low risk devices to higher risk IVDs and medical devices.

CLEANROOM CONSUMABLE MANUFACTURING

We have an ISO 7 certified on-site cleanroom to manufacture sterile consumables. We are experienced in processes including solvent bonding, ultrasonic welding, leak testing, air particle testing, heat sealing, gamma sterilization, bioburden and sterility testing. 

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.

FLEXIBLE AND RESPONSIVE SERVICE
  • Tailored open book supply and quality agreements
  • Established Low Cost Region and Australian supply chains
  • Dedicated product managers with technical and commercial capability