Quality means much more than compliance. For quality to prevail it must be a daily obsession shared by every person during every moment of every day.
ISO 13485 & 9001 certified
Our Quality Management System is certified to ISO 13485:2016 and ISO 9001:2015 and is designed to ensure that all products are fit for their intended purpose, meet the required specifications for quality and safety, and comply with regulatory requirements and the marketing authorisation. We are audited annually by our ISO certification partner, BSI.
What's more, we understand and are committed to protecting your business from the potentially drastic implications of regulatory non-compliance including termination of market approval and/or refusal of new filings.
Good Manufacturing Practices (GMP)
We demonstrate unwavering regulatory commitment and compliance to international GMP standards for medical devices. All our manufacturing activities occur under strict GMP requirements with the goal of ensuring product quality as well as safeguarding the health of consumers and patients.
This includes strict compliance and consistent controls governing cleanliness, contamination, manufacturing procedures, record keeping and quality assurance.
We have extensive cleanroom areas which are designed and built as ISO 7 cleanrooms. Incoming air is filtered and supplied to all cleanroom areas; which have air locks, pressure differentials, air exhaust and special cleanroom gowning requirements. Pressure differentials are in a cascading arrangement to ensure clean air flows from the ‘inner’ more critical rooms to the airlocks, and then outer corridors.
We put security at the centre of all information services and infrastructure, using ISO27001 and Australian Security Directorate's Essential 8 as our benchmark. We also conduct twice annual security reviews to provide updated mitigation strategies against a broad range of cyber threats customised for our risk profile.
We actively promote a culture of quality within our workforce. Quality requirements are deeply embedded into the daily operations of all employees and management alike. Employees understand their part in the importance of meeting quality and regulatory requirements, as well as client requirements.
We have also adopted a culture of continuous improvement and constantly seek to improve our business conduct, valuing and enhancing the highly skilled input of employees by providing a safe and stimulating work environment, partnering with clients to assist in the achievement of their goals, and striving for best practice in the development and manufacture of micro-engineered devices.