Regulatory

  • DESIGN FMEA – MINIMISING RISK

    We ensure risk is minimised through the design process by undertaking Design Failure Mode Effects Analysis, as part of the development process.

  • MEDICAL DEVICE STANDARDS

    We ensure your products meet the required standards. We have associate regulatory specialists to undertake this for any medical device development.

  • MEDICAL DEVICE SYMBOLS

    We ensure the relevant symbols are displayed on your medical device. These will either be engraved on the plastic moulding or on a printed label.

  • REGULATORY PACKAGING LABEL

    We can design your product label, ensuring the required information, such as medical device symbols and expiry dates are clearly shown