Medical Device

Medical Device industry challenges

Infection and microbial contamination control is one of the essential principles in the The Australian Regulatory Guidelines for Medical Devices (ARGMD). Even after sterilization, any residual surface contamination left on the device before sterilization remains after the process and can pose a risk to patient safety.

Our mission is to provide quality solutions through specialized products and services that minimize the risks associated with contaminants and residues.

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8.1 Minimisation of risk of infection and contamination

A medical device must be designed and produced in a way that ensures that the risk of infection to a patient, a user, or any other person, is eliminated or minimised.

Therapeutic Goods (Medical Devices) Regulations 2002

Our solutions for medical device manufacturers

Quality assurance

We are fully accredited under AS/NZS ISO 9001: 2008 Quality Management Systems. Our qualified laboratory staff can provide specialised testing services, including test methods development and validation to support your compliance needs.

Non linting garments

CRG uses synthetic fabrics to prevent shedding or linting of particles and fibres designed specifically for use in the pharmaceutical and drug manufacturing industries. Our critical wash and sterilization process will ensure the highest level of cleanliness.

Contaminants and contaminant removal

Any residual surface contamination left on the device before sterilization remains after the process and can pose a risk to patient safety. We offer a wide range of medical device cleaning products including low-linting wipes and swabs to assist in producing a clean medical device.

Medical Device product recommendations

See all products

Medical Device industry challenges

Therapeutic Goods (Medical Devices) Regulations 2002

Our solutions for medical device manufacturers

Quality assurance

Non linting garments

Contaminants and contaminant removal

Medical Device product recommendations

Bioclean-d Drop-down Sterile Garment With Hood

Bioclean Extra Sterile Latex Gloves (16″)

Bioclean-d Coverall With Hood

Bioclean Maxima Sterile Latex Gloves (24″)

Bioclean-d Sleeve Covers

Bioclean-d Hood

Kimtech Pure G3 Sterile Latex Gloves

Bioclean-d Overshoes

Bioclean Indigo Sterile Nitrile Gloves

Bioclean N-plus Sterile Nitrile Gloves (16″)

Bioclean Emerald Sterile Nitrile Gloves

Bioclean Excell Sterile Nitrile Gloves

Bioclean Jade Sterile Nitrile Gloves

Kimtech Pure G3 Sterile Nitrile Gloves

Bioclean Ultimate Sterile Polychloroprene Gloves

Bioclean P-zero Sterile Polychloroprene Gloves

Bioclean Suprene Sterile Neoprene Gloves

Bioclean Legacy Non Sterile Latex Gloves

Kimtech Science Pfe-xtra Latex Gloves

Bioclean Vista Non Sterile Vinyl Gloves

Rapini Storage

Tubular Stainless Steel Linen Skip

Cleanroom First Step Mat

CRG Micron Tacky Mat

Bioclean Nerva Non Sterile Nitrile Gloves (16″)

Bioclean Nano 4 Non Sterile Nitrile Gloves

Omega Pro-tech Xp Non Sterile Nitrile Gloves

Kimtech Pure G3 Critical Nitrile Gloves

Kimtech Pure G3 Nxt Nitrile Gloves

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