Regulatory / Registrations
| Regulatory / Registrations | |
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MedApps has gone through the rigorous task of building its Quality Management System (QMS) and has received two FDA Clearances: K062377 (Glucose) and K083862 (HealthPAL, Scale, Blood Pressure and Pulse Oximeter). This is one of our biggest points of pride: Being FDA Cleared. We have taken the time, and made the financial and resource commitment to make sure that we are in compliance with all applicable laws, and have patient safety, privacy and well being at the forefront of our minds at all times. |
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Health Canada / Santé Canada Clearance MedApps has received its Health Canada License : 81920, which allows MedApps to sell HealthPAL devices in Canada. |
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ISO 13485:2003 / ISO 9001:2008 / MDD / CE Mark Registration MedApps has received its IS0 13485:2003, ISO 9001:2008 and CE Mark issued by Underwriters Laboratories (UL). The completion of this multi-year project will enable MedApps to distribute throughout Europe, and the ISO 13485 needed for Health Canada. |
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