As a UL certified company, MedApps has gone through the rigors of building a sound regulatory foundation and the Company has achieved numerous regulatory certifications including two FDA clearances which covers usage in monitoring glucose, blood pressure, weight, and blood oxygen saturation (SpO2). MedApps recently completed a successful FDA general audit which validated the Company’s ISO certified Quality Management System as being compliant with the FDA’s 21 CFR Part 870 standards.
MedApps’ product roadmap includes integration to more FDA-cleared peripheral monitoring devices from an expanded number of manufacturers; as well as additional modalities including PT\INR (for blood coagulation), ECG, pedometer and peak flow / spirometer; and internal monitors devices such as loop recorders, continuous glucose monitors and insulin pumps.
MedApps significant regulatory achievements include ISO 13485 / ISO 9001: 2008, CE Mark and Health Canada certification.
MedApps is an active member of Continua and will implement the standards set by Continua and other industry organizations, once adopted by the Institute of Electrical and Electronics Engineers. The IEEE is a professional association for the advancement of technology (11073 Standards).
Allows MedApps to market its products and services in the European Union.
Health Canada License 81920: Allows MedApps to market its products and services in all provinces of Canada.
• 16 US Patents Allowed
• 27 Patent Applications (US & Foreign)
• 20 Trademark Applications
• FDA General Audit (Jul 2011)
• Health Canada License (Jan 2010)
• 3 FDA Clearances
(Jul 2007, Jun 2009, Dec 2011)
• ISO 9001:2008 (Dec 2009)
• ISO 13485:2003 (Dec 2009)
• UL Registered (Dec 2009)
• CE Mark (Dec 2009)
• FCC Compliance
• PTCRB Certification
• AT&T Certification
• Verizon Certification
• 2011 Edison Award - New product