Regulatory Compliance Information
Formed in 1998 (originally as iMetrikus), Numera works with partners to achieve Measurably better health™ and wellness for those in their care through encouragement, support and accountability. The company combines the power of caregivers, friends and peer groups, subjective and objective health information and the ability to make this information actionable via extensible, scalable and custom-branded solutions.
Focused on Healthy Aging, Chronic Conditions and Post-Acute Care, Numera's solutions help people live healthier longer. These solutions extend beyond traditional emergency response to home health management, population care management and social engagement – all based on the company's FDA-cleared telehealth+telecare platform.
Numera has developed a Quality Management System to meet and exceed the standards and regulations of the U.S. 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
- ISO 13485:2003
- FDA Registration (#2032583)
Product Clearances and Certifications
- U.S. Food &Drug Administration - 510(k) (#K091021)
- TÜV SÜD America Product Certification:
- CAN/CSA-C22.2 No. 60601-1:2008,
Excluding:Usability (clauses 7.1.1 and 12.2), EMC (clauses 126.96.36.199 and 17), and Biocompatibility (clause 11.7)
- UL 60601-1:2003,
Excluding:EMC (clauses 6.8.2 and 36) andBiocompatibility (clause 48)
- ANSI/AAMI ES 60601-1/A2:2010,
Excluding:Usability (clauses 7.1.1 and 12.2),EMC (clauses 188.8.131.52 and 17) and Biocompatibility (clause 11.7)
Declaration of Conformity
- MetrikLink® (available upon request)
- Home Hub™(available upon request)
Authorized European Representative
2513 BH, The Hague