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.

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—Schedule 1, Part 2

OUR SOLUTIONS FOR MEDICAL DEVICE MANUFACTURERS

  • 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.

  • 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.

  • 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.

CONTACT US

Our sales team can help you choose the right solutions for your cleanroom and contamination control requirements.