E-QURE is operated Internationally and is led by a management team with extensive experience in electrotherapies, medical technologies, wound care, regulatory affairs and finance. E-QURE - international operations focus on managing the processes of design, production, regulation, and distribution of the company products and services.
Quality Assurance - QA
E-QURE adheres to the highest standards for the design and manufacture of medical devices. Our quality management system is certified for ISO9001:2008, ISO 13485:2003 and Annex II of MDD 93/42/EEC, and complies with the US Quality System Regulation 21 CFR 820. Our products comply with the requirements of the EU Medical Devices Directive 93/42/EEC.
- EC Certificate, Directive 93/42/EEC Annex II, full quality assurance system -- E-QURE BST device for the treatment of chronic ulcers.
- ISO 9001:2008 -- Design, manufacture, marketing and servicing of medical electrical stimulation devices.
- ISO 13485:2003 – Design, manufacture, marketing and servicing of medical electrical stimulation devices.
- CAN/CSA ISO 13485:2003 -- Design, manufacture and servicing of medical electrical stimulation devices for treatment of chronic ulcers.