Certifications

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.

CE	Self-declared CE marked product based on the MDD Declaration of conformity. This allows Smartz Product to be marketed
ISO 13485	Our Quality Management Systems (QMS) is certified to ISO 13485:2016, the internationally recognised standard specific to the medical device industry.
FDA	As an FDA Registered Facility, our systems and processes also comply with the FDA Quality System Regulations 21 CFR Part 820.
GMP	Our on-site manufacturing operates under strict Good Manufacturing Practices (GMP), ensuring product quality and integrity.