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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 patient monitoring accessories meet (and often exceed) these standards. For our customers, this diligence and assurance delivers peace of mind.

ISO 13485

This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

AAMI/EC53

The Association for the Advancement of Medical Instrumentation (AAMI) is the primary source of consensus standards for the medical device industry. Their EC53 Standard covers safety and performance requirements for disposable and reusable ECG cables and lead wires.

UL TESTING CAPABILITIES

In order to evaluate and certify products, UL uses product samples in their test processes. While UL maintains their own extensive test facilities, a select number of their customers (such as Curbell) qualify to utilize their own in-house test facilities and equipment under the supervision of UL personnel.

QSR COMPLIANCE

Specific to FDA Medical Devices, this refers to Quality System Regulation. A quality system is a necessary component of any medical device commercialization effort. For medical device manufacturers seeking regulatory clearance or approval in the US, 21 CFR Part 820 of US Code of Federal Regulations is necessary to meet quality system requirements (QSR) and bring their products to market.

C-TPAT

C-TPAT (Customs-Trade Partnership Against Terrorism) is a voluntary public-private sector partnership program which recognizes that US Customs and Border Protection can provide the highest level of cargo security only through close cooperation with the principle stakeholders of the international supply chain such as importers, carriers, consolidators, licensed customs brokers, and manufacturers.

INTERNATIONAL COMPLIANCE

  • EU MDR (European Medical Device Regulations)
  • MDR of Canada (Canadian Medical Device Regulations)
  • RoHS (Restriction of Hazardous Substances) — a European directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment. (i.e. Lead, Mercury, Cadmium)
  • REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) — a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals.