Our Commitment to Quality
- Our technology and solutions are of the highest standard.
- Our research, development, and manufacturing are of the highest quality.
- Our people are of the highest calibre.
- Our partners are world class.
||Self-declared CE marked product based on the MDD Declaration of conformity. This allows Smartz Product to be marketed
||The Smartz System has been included in the ARTG based on the Self declaration process.
||Our Quality Management Systems (QMS) is certified to ISO 13485:2016, the internationally recognised standard specific to the medical device industry.
||As an FDA Registered Facility, our systems and processes also comply with the FDA Quality System Regulations 21 CFR Part 820.
||Our on-site manufacturing operates under strict Good Manufacturing Practices (GMP), ensuring product quality and integrity.