QUALITY AND REGULATORY COMPLIANCE
Quality is much more than an adjective used to describe our products. For us, it’s an entire system that guides the design and manufacture of those products, many of which are regulated medical devices. Our Quality and Regulatory team understands the procedures necessary for assuring compliance with all applicable industry standards so we can make sure that our products meet (and often exceed) these standards. For our customers, this diligence and assurance delivers peace of mind.
ISO 13485:2016
This standard specifies quality management system requirements for organizations that manufacture medical devices and related services to consistently meet customer and regulatory requirements.
AAMI/EC53
The Association for the Advancement of Medical Instrumentation (AAMI) develops consensus standards for the medical device industry. Its EC53 standard defines safety and performance requirements for disposable and reusable ECG cables and lead wires.
UL TESTING CAPABILITIES
UL evaluates and certifies products by testing product samples. While UL operates its own testing facilities, qualified companies such as Curbell may perform testing in their own laboratories using approved equipment under the supervision of UL personnel.
QMSR COMPLIANCE
For FDA medical devices, the Quality Management System Regulation (21 CFR Part 820) defines the quality system requirements manufacturers must follow to ensure product quality and gain approval to market devices in the US.
C-TPAT
C-TPAT (Customs-Trade Partnership Against Terrorism) is a voluntary public-private partnership that strengthens cargo security through cooperation between US Customs and Border Protection and international supply chain stakeholders.
INTERNATIONAL COMPLIANCE
- MDR of Canada (Canadian Medical Device Regulations)
- RoHS (Restriction of Hazardous Substances) is a European directive that restricts the use of hazardous substances (such as lead, mercury, and cadmium) in electrical and electronic equipment.
- REACH is an EU regulation that protects human health and the environment by controlling the use of chemicals.