Regulatory

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).

Made in the USA

MedApps products and services are proudly developed and manufactured in the United States. We create all of our solutions in-house with a talented team of designers and engineers. We use only contract manufacturers that meet and exceed the same ISO certified industry standards that we aspire to and achieve.