QM System EN ISO 13485
PharmACT manufactures medical devices using the ISO 13485 quality assurance system. The QM system is based on ISO 9001, but takes into account the special requirements for manufacturers of medical devices and in-vitro diagnostics (IVD).
Our current certification according to ISO 13485 took place in 2018. With the auditing, we have achieved the certainty that the requirements for the development, manufacture and testing, as well as the placing on the market and monitoring of our products comply with the legal requirements of the Medical Devices Directive and the In Vitro Diagnostics Directive.
As a manufacturer of medical devices it is our goal to sell the IVD rapid test developed and produced by us worldwide. By means of ISO 13485 we have achieved the possibility to comply with the Food and Drug Administration Quality System Regulation (QSR). The FDA QSR (21 CFR Part 820), for example, requires us as a manufacturer to use a quality system for the design, manufacture, packaging, labelling, storage and delivery of medical devices. This requirement is also generally known as Good Manufacturing Practice (cGMP or GMP).
We are working to extend our existing ISO 13485 quality management system to include GMP requirements. The extension will ensure that all requirements of the European CE marking, the Canadian Medical Devices Regulations and the Japanese Ordinance #169 can be met.