Both the clinical and the EPR elements of MobiMed are certified under MDD (Medical Device Directive) IIb and thus already satisfy forthcoming reclassification for documentation and archive systems.
Ortivus successfully master all the medical device regulatory requirements even though a great deal of the products are based on IT and wireless communication by using a risk based approach and a clear system architecture.
Both the Clinical and the ePR part of MobiMed are certified according to MDD, class IIb (Medical Device Directive) and meets thereby already now the upcoming reclassification of documentation and record systems.
European Union
Ortivus headquarters in Sweden develops and produces medical technology products for heart monitoring and electronic record keeping. The cardiological monitoring products are classified as high risk by the EU medical technology directive, MDD. Ortivus has decided to adopt a complete quality management system certified under ISO 13485:2003 to meet the requirements in Appendix II of the MDD, thereby allowing the products to be marketed. The quality management systems allow Ortivus to be a cutting-edge enterprise and to continually improve our products and processes. In the case of electronic patient records, Ortivus sits on the international technical committees which set the norms in the field. Ortivus actively monitors forthcoming regulations so as to approach them proactively. Ortivus is currently in a good position to meet future directives and regulations.
North America and Canada
Ortivus has adapted its quality management system to meet the North American directives and legislation CMDCAS (Canada); QSR (USA). The chief focus for the North American companies lies in meeting product requirements and standards, such as NEMSIS.
Environment
Ortivus is environmentally active. The ambition at Ortivus is that as few environmentally harmful materials as possible are used in product manufacture and shipping. Packaging, accessories and future repairs are also reviewed from an environmental perspective. A product’s components must be easily traceable. Ortivus products are assembled from standardised components purchased from sub-contractors. Ortivus has certain proprietary hardware that is manufactured by sub-contractors according to our specifications. Ortivus does not manufacture any hardware components itself. Environmental considerations are an important criterion in the selection of sub-contractors. Materials, components and production methods are selected by Ortivus in conjunction with the sub-contractor.