|
Formed in 1998, iMetrikus® is a healthcare technology company with principal offices in Sunnyvale, California. iMetrikus specializes in interactive health management and remote patient monitoring for populations with conditions that include asthma, diabetes, COPD, cardiovascular disease, obesity as well as general wellness. We market in the United States and internationally through payers, integrated delivery networks, and pharmacies.
iMetrikus has developed a Quality Management System to meet and exceed the standards and regulations of the U.S., Canada and European Union. All registrations, certifications and licenses are maintained to ensure that current U.S. and international standards are satisfied. In the U.S., we are in compliance with FDA Regulation, 21 CFR Part 820, Quality System Regulations.
Quality Management System
Product Clearances and Certifications
- FDA 510(k) – MediCompass® Connect (search for #K091021)
- FDA 510(k) – Airwatch® (search for #K982676)
- MDD 93/42/EEC Certificate – Airwatch®
Declarations of Conformity
|
|
Notified Body Information
BSI Management Systems
12110 Sunset Hills Road
Suite 200
Reston, VA 20190 USA
Phone: 1.800.862.4977
Fax: 1.703.437.9001
Website: www.bsiamerica.com
|
Authorized European Representative Information
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31.70.345.8570
Fax: +31.70.346.7299
Website: www.emergogroup.com
|
