Our CGM systems are developed, tested, and manufactured under certified quality management and international standards. We maintain a full suite of validation reports, test records, and compliance certificates, all available to support your CE-MDR, FDA, or other regulatory submissions.
Contact usStruggling to navigate local regulations? Our CGMS comes with a complete package of documentation that helps you accelerate submissions, reduce review cycles, and get to market faster.
Pre-built validation documentation helps you fast-track CE-MDR, FDA, and other market entry submissions.
Audit-ready test reports from ISO13485-certified facilities give you confidence during regulatory reviews and partner audits.
Well-documented quality systems and validated performance data strengthen your brand's credibility with healthcare professionals.
As a CGM manufacturer, we maintain structured documentation that can be shared with qualified partners under NDA to support your regulatory filing.
Tell us which certifications, test reports, or validation documents you need for your target market.
We provide the complete technical file package, including test results, certificates, and supporting study data, formatted for regulatory submission.
Your team integrates the documentation into your own regulatory dossier and files with the relevant health authority in your market.
We hold all necessary certifications and validation reports to support your regulatory submissions. Here are a few of them below.
Certification of our quality management system for the design, development, and manufacturing of CGMS.
Confirms that materials contacting the patient's skin do not cause cell death or toxic reactions.
Evaluates whether any component of the CGM system may cause allergic reactions or skin sensitization after repeated contact.
Testing related to potential harmful biological effects after systemic exposure to product materials.
Determines whether the sensor, adhesive, or other skin-contacting materials cause redness, swelling, or tissue damage.
Summarizes clinical study data demonstrating the Mean Absolute Relative Difference (MARD) of our CGM system, a key accuracy metric.
Assessment of biological safety and compatibility between the device and the human body.
Documents that our sterilization process consistently achieves a sterility assurance level (SAL).
Proves that our in-house calibration process consistently sets sensor accuracy before shipment, reducing or eliminating fingerstick calibration.
Data from real-time and accelerated aging studies confirming sensor performance and battery life over the labeled shelf life.
Analysis and identification of chemical substances associated with product materials.
Measures potential chemicals that may leach from sensor materials into the body under simulated use conditions, supporting biocompatibility.