Sparkle’s manufacturing facility has been audited by independent third-party organizations to verify that 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 have met all the strict regulatory requirements for our medical devices through increased transparency while maintaining high-quality standards through 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.
US FDA (The US Food and Drug Administration) is an American organization responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices.