Any Australian manufacturer of a medical device or IVD higher than a Class I must have a Quality Management System. These systems are required by regulators in most regions because they define and control how medical products are developed, documented, released, modified, manufactured, traced, maintained, and also recalled.
A Quality Management System is made up of a set of procedures, forms, registers, and resources designed to work for your organisation and assist in demonstrating regulatory and process compliance. KD&A Quality Management Systems are based on ISO 13485, which while similar to ISO 9001, is specifically structured for medical device and IVD manufacturers. ISO 13485 focuses on device traceability, conformity, and contamination control.
At KD&A we specialise in designing Quality Management Systems for medical device and IVD organisations. We create Quality Management Systems that are flexible to grow and develop as your organisation does, and most importantly, that demonstrate compliance to regulatory requirements. You need a system that supports and enhances your organisation, not one that weighs it down.
Employee training is an important part of implementing and maintaining a Quality Management System. As an additional service, KD&A can provide Quality Management System training as well as ongoing maintenance services – to ensure that your system remains compliant and effective.
Indicative Fee: between AUD$11,250 and AUD$13,500 plus GST. This fee is dependant on device type and complexity, and organisation structure.
Other relevant services:
Contact us if you require a custom quote.
Have a few questions? Visit our Frequently Asked Questions page.