Quality Assurance and Product Safety
MedApps works closely with appropriate regulatory agencies, such as the FDA and FCC, to ensure patient confidence and safety as we bring quality technologies and capabilities to market.
Currently the MedApps Quality Management System is on target for achieving ISO 13485 certification, which will be followed by the European Union's health, safety and environmental standards "CE Mark" for the company's entire product line.
MedApps is a member of Continua and will be incorporating the new ISO 11073 standards for home-based monitoring devices once those standards have been fully adopted.
Additionally, MedApps utilizes usability and human factors testing and complies with:
• The American Disabilities Act
• ROHS (Lead Free Components)
• EMI / EMC Testing (Electromagnetic Interference/Electromagnetic Compatibility)
• PTCRB Certification (Cellular Certification)