Quality Assurance
Resonance Health is committed to quality and to consistently providing devices and services that meet or exceed the requirements and expectations of our customers and applicable regulatory requirements.
We achieve this through the company‑wide commitment to our core values:
We are dedicated to actively engaging with our stakeholders to continuously improve our devices and services, to ensure full compliance with regulatory obligations, and the effectiveness of our Quality Management System.
Our Quality System is designed to fully meet the requirements of:
- ISO 13485, Medical devices – Quality management systems – requirements for regulatory purposes
- Food and Drug Administration (FDA) Quality System Regulation (QSR), Part 820 – Quality System Regulation
- Official Journal of the European Communities, Regulation (EU) 2017/745 of the European Parliament and Council, 5 April 2017, on medical devices
- Therapeutic Goods Act 1989
- Therapeutic Goods (Medical Devices) Regulations 2002
- Australian Regulatory Guidelines for Medical Devices 2011
- FDA 21 CFR Part 11 – 21 CFR Part 11 compliance in clinical trials is mandated by the FDA. More broadly, 21 CFR Part 11 applies to all industries under FDA’s regulation including biopharmaceuticals and medical devices. Its core purpose is to regulate electronic records and signatures to ensure their integrity, accuracy and confidentiality