Sparkle’s state-of-the-art manufacturing facility has been audited by independent third party organizations to verify our quality management and product safety protocols meet international standards. Besides being US FDA registered, our manufacturing facility is also ISO 13485 and ISO 9001 certified.
ISO 13485 certification demonstrates that we meet strict regulatory requirements for our medical devices through increased transparency and maintain high quality standards though documentation, tracking, and feedback loops.
ISO 9001 focuses on quality and consistency. It ensures that we deliver high quality products consistently that meet all regulatory requirements.