Quality Management System for Medical Devices – ISO 13485
Within RI a dedication to quality permeates all that we do. All RI products are designed, developed and manufactured within an ISO 13485 environment.
All materials and packaging used within the manufacturing process of RI medical devices are comprehensively tracked and logged to ensure full traceability.
We hold certification to ISO 9001, ISO 13485 (including CMDCAS and TFDA GMP) and Medical Device Directive 93/42/EEC as amended.
Continual evaluation of our products has led to the creation of the finest range of devices on the market that clinics aspire to own and use.
All RI medical devices carry the CE mark.
The CE mark shows that RI’s products comply with the Essential Safety Requirements of the European Medical Device Directive (93/42/EEC) as amended.
Many of our medical devices also have USA FDA market clearance, Health Canada medical device licenses and certification in Taiwan and China.
We are continuously working to expand our registration with the relevant medical device authorities across the world.
RI’s range of consumables must pass stringent testing and inspection criteria to ensure that you receive the most consistent and high quality product.
Mouse Embryo Assay (MEA) for embryo toxicity
Each sterility batch of finished product is tested by an independent laboratory using a 1-cell stage mouse embryo toxicity test. Embryos are also assessed at critical development points during the MEA to ensure maximum test sensitivity. Non-embryotoxic proven by Mouse Embryo Assay (MEA), Pass Level: Day 2 ≥80% 2-cells, Day 6 ≥80% blastocysts.
Limulus Amoebocyte Lysate (LAL) for endotoxins
Each sterility batch of finished product is tested for bacterial endotoxins. Our pass criteria is < 20Eu per device.
Human Sperm Survival Assay (HSSA)
Each sterilisation batch of finished injection pipettes within the RI Pipette range undergoes a sperm motility bio assay. To pass the HSSA test, the motility of sperm should be ≥ 70% after 24 hours of sample preparation.
Where applicable, products are sterilised by an approved gamma irradiation facility meeting ISO 11137 standards to a sterility assurance level (SAL) of 10-6. The shelf life of our pouch packed products is 3 years and for our blister packed products, 5 years.
Cleanroom Manufacturing Facilities
RI consumables are manufactured and packaged in an ISO 14644 cleanroom. Our highly trained pipette manufacturing personnel inspect each individual unit at every step of the production process to ensure only the highest quality devices reach your laboratory. Our quality control protocols require that micropipettes are examined five times before production is completed.