ISO Certification, Quality Assurance & Standards
Quality Management & Standards
ARC Healthcare Solutions is committed to designing and manufacturing products that continually meet customer requirements. ARC’s quality management system (QMS) outlines the business practices used to meet customer needs while satisfying the regulatory requirements of the industry. Our quality management system provides a system for monitoring and improving performance. ARC’s QMS meets the requirements of ISO 13485:2003 (International Standards for Medical Devices), holds an MDEL Licence for the Class I devices and a Class II Licence for our Class II Device. View our ISO 13485 certificate here...
ISO 13485
ARC Healthcare Solutions is certified under ISO 13485:2003 International Standards for Medical Devices. ISO 13485 is an internationally recognized quality management system (QMS) standard for the design and manufacture of medical devices. The standard focuses on consistently meeting customer and regulatory requirements that are applicable to medical devices industry. It demonstrates a commitment from management for quality throughout the product development life-cycle and the product’s lifespan with customers.
Health Canada Medical Device Regulation
ARC Healthcare Solutions has its Health Canada Class I & II Medical Device Licenses. Health Canada’s medical device regulations are used to monitor and evaluate the safety, efficacy, and the quality of medical devices so that consumers and healthcare professionals can use them with confidence. Medical devices can be categorized under four classes depending on the risk potential associated with the device; ARC’s product fall under Class I or Class II and pose a fairly low risk potential. Health Canada’s regulations provide a framework for monitoring devices to ensure they are safe and effective.
ARC Healthcare Solutions is committed to designing and manufacturing products that continually meet customer requirements. ARC’s quality management system (QMS) outlines the business practices used to meet customer needs while satisfying the regulatory requirements of the industry. Our quality management system provides a system for monitoring and improving performance. ARC’s QMS meets the requirements of ISO 13485:2003 (International Standards for Medical Devices), holds an MDEL Licence for the Class I devices and a Class II Licence for our Class II Device. View our ISO 13485 certificate here...
ISO 13485
ARC Healthcare Solutions is certified under ISO 13485:2003 International Standards for Medical Devices. ISO 13485 is an internationally recognized quality management system (QMS) standard for the design and manufacture of medical devices. The standard focuses on consistently meeting customer and regulatory requirements that are applicable to medical devices industry. It demonstrates a commitment from management for quality throughout the product development life-cycle and the product’s lifespan with customers.
Health Canada Medical Device Regulation
ARC Healthcare Solutions has its Health Canada Class I & II Medical Device Licenses. Health Canada’s medical device regulations are used to monitor and evaluate the safety, efficacy, and the quality of medical devices so that consumers and healthcare professionals can use them with confidence. Medical devices can be categorized under four classes depending on the risk potential associated with the device; ARC’s product fall under Class I or Class II and pose a fairly low risk potential. Health Canada’s regulations provide a framework for monitoring devices to ensure they are safe and effective.
