We are ISO-certified
Ortivus quality system ensures that our processes and solutions are continuously improved. The company is proactively working to meet future changes in regulations and directives. Improvement work is always carried out with a focus on customer expectations in regards to healthcare outcome and efficiency.
Our certifications prove to Ortivus customers, partners and suppliers that the organisation prioritizes continuous improvement in order to deliver the services at the right quality.
Ortivus currently has the following certifications:
- ISO 20000 IT Service Management
- ISO 27001 Information Security Management Systems
- ISO 13485 Quality Management System for the Design and Manufacture of Medical Devices
Both the clinical and the ePR part of MobiMed Smart is CE marked according to MDD (Directive 93/42 / EEC Medical Devices Directive, Annex II) and thus meets the requirements for documentation and archiving system.
Ortivus has an active environmental policy. The ambition is to use as few as possible hazardous substances in the manufacture of our products and for shipment to the customer. Also the packaging, accessories and repairs are examined from an environmental perspective. The products should be easily separated into its components. Ortivus products are composed of standardized components purchased from suppliers. Ortivus has some proprietary hardware that is manufactured by subcontractors according to company specifications. The company has therefore no production of hardware components in-house. In the selection of subcontractors is environmental management an essential decision criterion. Ortivus chooses consumables, components and production methods in cooperation with the subcontractors.
Ortivus products complies with the RoHS Directive on the restriction of use of hazardous substances in electrical and electronic products.