CGM certifications & validations
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.
Your compliance, simplified
Struggling 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.
Accelerate regulatory filing
Pre-built validation documentation helps you fast-track CE-MDR, FDA, and other market entry submissions.
Reduce compliance risk
Audit-ready test reports from ISO13485-certified facilities give you confidence during regulatory reviews and partner audits.
Build brand trust
Well-documented quality systems and validated performance data strengthen your brand's credibility with healthcare professionals.
How do we support your compliance preparation?
As a CGM manufacturer, we maintain structured documentation that can be shared with qualified partners under NDA to support your regulatory filing.
You request the documents
Tell us which certifications, test reports, or validation documents you need for your target market.
We compile and deliver
We provide the complete technical file package, including test results, certificates, and supporting study data, formatted for regulatory submission.
You submit to authorities
Your team integrates the documentation into your own regulatory dossier and files with the relevant health authority in your market.
Validation & Certification gallery
We hold all necessary certifications and validation reports to support your regulatory submissions. Here are a few of them below.
ISO13485 Certificate
Certification of our quality management system for the design, development, and manufacturing of CGMS.
Cytotoxicity report
Confirms that materials contacting the patient's skin do not cause cell death or toxic reactions.
Sensitization report
Evaluates whether any component of the CGM system may cause allergic reactions or skin sensitization after repeated contact.
Systemic toxicity report
Testing related to potential harmful biological effects after systemic exposure to product materials.
Irritation report
Determines whether the sensor, adhesive, or other skin-contacting materials cause redness, swelling, or tissue damage.
MARD clinical performance
Summarizes clinical study data demonstrating the Mean Absolute Relative Difference (MARD) of our CGM system, a key accuracy metric.
Biocompatibility evaluation
Assessment of biological safety and compatibility between the device and the human body.
Sterilization validation
Documents that our sterilization process consistently achieves a sterility assurance level (SAL).
Factory calibration validation
Proves that our in-house calibration process consistently sets sensor accuracy before shipment, reducing or eliminating fingerstick calibration.
Stability & shelf-life validation
Data from real-time and accelerated aging studies confirming sensor performance and battery life over the labeled shelf life.
Chemical characterization report
Analysis and identification of chemical substances associated with product materials.
Leachables testing report
Measures potential chemicals that may leach from sensor materials into the body under simulated use conditions, supporting biocompatibility.